Trial Outcomes & Findings for A Study to Assess Recovery and Survival of Radiolabeled Apheresis Platelet Components Treated With the INTERCEPT Blood System for Platelets With LED Illuminator. (NCT NCT06697223)
NCT ID: NCT06697223
Last Updated: 2026-08-04
Results Overview
Recovery of Test platelets stored for 5 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66\*Control) in survival is greater than or equal to zero.
COMPLETED
PHASE2
40 participants
11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets
2026-08-04
Participant Flow
A subject was considered "enrolled" upon signing the informed consent form.
Subjects who initiated an apheresis collection were included in the ITT/Safety Analysis Set. Subjects who had data for recovery and survival data and/or other in vitro characteristics were in the the Modified Intention to Treat (mITT). Randomized and infused subjects who had both paired (Test and Control) recovery and paired survival data, Test recovery and/or survival less than Control recovery and/or survival and complied with the protocol were in the Per Protocol Set (PPS).
Participant milestones
| Measure |
Simultaneous Administration of Test and Control Platelets
INTERCEPT treated platelets (Test) from 24 healthy subjects, stored for 5 days, were prepared for radiolabeling following the Variant 1 methodology. The radiolabeled autologous Test and Control platelets, approximately 5 to 30 mL, were simultaneously administered intravenously into the subject.
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|---|---|
|
Overall Study
STARTED
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40
|
|
Overall Study
Started Apheresis
|
29
|
|
Overall Study
Successful Apheresis Collection
|
27
|
|
Overall Study
Completed 5-days Storage of Test Platelet Component
|
27
|
|
Overall Study
Completed Post Infusion Sampling
|
27
|
|
Overall Study
Per Protocol Set
|
24
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Simultaneous Administration of Test and Control Platelets
INTERCEPT treated platelets (Test) from 24 healthy subjects, stored for 5 days, were prepared for radiolabeling following the Variant 1 methodology. The radiolabeled autologous Test and Control platelets, approximately 5 to 30 mL, were simultaneously administered intravenously into the subject.
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|---|---|
|
Overall Study
Screen Failure
|
7
|
|
Overall Study
Due to scheduling
|
2
|
|
Overall Study
Weather forcast
|
2
|
|
Overall Study
Apheresis collection not successful
|
2
|
Baseline Characteristics
A subject was considered "enrolled" upon signing the informed consent form. ITT comprised of all randomized subjects who initiated an apheresis collection. There were 29 subjects included in the ITT.
Baseline characteristics by cohort
| Measure |
Started Apheresis
n=29 Participants
A subject was considered "enrolled" upon signing the informed consent form. Intention to Treat (ITT) group included subjects who initiated an apheresis collection. There were 29 subjects in the ITT.
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|---|---|
|
Height
|
175.5 cm
STANDARD_DEVIATION 10.6 • n=20 Participants
|
|
Weight
|
83.0 kg
STANDARD_DEVIATION 15.0 • n=20 Participants
|
|
Blood Type
A
|
12 Participants
n=20 Participants
|
|
Blood Type
B
|
3 Participants
n=20 Participants
|
|
Blood Type
O
|
11 Participants
n=20 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants • A subject was considered "enrolled" upon signing the informed consent form. ITT comprised of all randomized subjects who initiated an apheresis collection. There were 29 subjects included in the ITT.
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=20 Participants • A subject was considered "enrolled" upon signing the informed consent form. ITT comprised of all randomized subjects who initiated an apheresis collection. There were 29 subjects included in the ITT.
|
|
Age, Categorical
>=65 years
|
5 Participants
n=20 Participants • A subject was considered "enrolled" upon signing the informed consent form. ITT comprised of all randomized subjects who initiated an apheresis collection. There were 29 subjects included in the ITT.
|
|
Age, Continuous
|
45 Years
STANDARD_DEVIATION 15 • n=20 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=20 Participants
|
|
Blood Type
AB
|
3 Participants
n=20 Participants
|
|
Rh Factor
Negative
|
1 Participants
n=20 Participants
|
|
Rh Factor
Positive
|
28 Participants
n=20 Participants
|
|
BMI
|
27.1 kg/m^2
STANDARD_DEVIATION 4.9 • n=20 Participants
|
PRIMARY outcome
Timeframe: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control plateletsPopulation: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
Recovery of Test platelets stored for 5 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66\*Control) in survival is greater than or equal to zero.
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
n=24 Participants
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
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|---|---|---|
|
Post Infusion Recovery of Test Platelets at End of 5 Day Storage
|
52.8 Percentage of infused platelets
Standard Deviation 11.4
|
64.2 Percentage of infused platelets
Standard Deviation 11.7
|
PRIMARY outcome
Timeframe: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control plateletsPopulation: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Survival of Test platelets stored for 5 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>58% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 \* Control) in survival is greater than or equal to zero.
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
n=24 Participants
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Post Infusion Survival of Test Platelets at End of 5 Day Storage
|
157.4 Hours
Standard Deviation 20.1
|
207.3 Hours
Standard Deviation 27.1
|
SECONDARY outcome
Timeframe: At the end of INTERCEPT treatment on Day 1 or Day 2Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Percentage of Test components with ≥ 3.0×10\^11 platelets
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Platelet Dose in Test Component
|
24 Participants
|
—
|
SECONDARY outcome
Timeframe: At the end of INTERCEPT treatment on Day 1 or Day 2Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Percentage of Test components with ≥80% platelet yield retention
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Platelet Yield Retention in Test Component
|
22 Participants
|
—
|
SECONDARY outcome
Timeframe: At end of 5 Day storagePopulation: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Percentage of Test components with pH 22°C ≥ 6.2
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
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|---|---|---|
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pH 22°C of Test Component
|
24 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before treatment on Day 0 or Day 1Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
Platelet dose was summarized descriptively for the Input components before treatment on Day 0 or Day 1
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of the Input Platelet Components: Platelet Dose
|
4.8 ×10^11 platelets
Standard Deviation 0.3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before treatment on Day 0 or Day 1Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
Component volume was summarized descriptively for the Input components before treatment on Day 0 or Day 1
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of the Input Platelet Components: Component Volume
|
357 mL
Standard Deviation 12
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After treatment on Day 1 or Day 2Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
Component volume was summarized descriptively for Test components after treatment on Day 1 or Day 2
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Test (INTERCEPT) Platelet Component: Component Volume
|
346 mL
Standard Deviation 13
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After treatment on Day 1 or Day 2Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
Platelet Dose was summarized descriptively for Test components after treatment on Day 1 or Day 2
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Test (INTERCEPT) Platelet Component: Platelet Dose
|
4.2 mL
Standard Deviation 0.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After treatment on Day 1 or Day 2Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
Platelet yield retention was summarized descriptively for Test components after treatment on Day 1 or Day 2
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Test (INTERCEPT) Platelet Component: Platelet Yield Retention
|
89 Percent retention
Standard Deviation 7
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
Component volume was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Component Volume
|
309 mL
Standard Deviation 14
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
Platelet count was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Platelet Count
|
1224 ×10^3 platelets/µL
Standard Deviation 95
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
Platelet Dose was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Platelet Dose
|
4.2 ×10^11 platelets
Standard Deviation 0.3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
Mean Platelet Volume was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Mean Platelet Volume
|
7.1 fL
Standard Deviation 0.6
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
pH was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: pH
|
7.3 pH
Standard Deviation 0.1
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
pO2 was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: pO2
|
148.6 mmHg
Standard Deviation 9.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
pO2 normalized for platelet count was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: pO2 Normalized for Platelet Count
|
52.7 µmol/hrs/10^12 cells
Standard Deviation 6.3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
pCO2 was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: pCO2
|
29.5 mmHg
Standard Deviation 2.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
pCO2 normalized for platelet count was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: pCO2 Normalized for Platelet Count
|
10.4 µmol/hrs/10^12 cells
Standard Deviation 0.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
HCO3 was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: HCO3
|
9.2 mmol/L
Standard Deviation 1.6
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
HCO3 normalized to platelet count was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: HCO3 Normalized to Platelet Count
|
7.5 mmol/10^12 cells
Standard Deviation 1.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome. PPS was the primary analysis population for the efficacy evaluation.
Supernatant glucose was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant Glucose
|
12.7 mmol/L
Standard Deviation 1.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Supernatant glucose normalized to platelet count was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant Glucose Normalized to Platelet Count
|
10.5 mmol/10^12 platelets
Standard Deviation 1.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Supernatant lactate was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant Lactate
|
8.5 mmol/L
Standard Deviation 1.3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Supernatant lactate normalized to platelet count was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant Lactate Normalized to Platelet Count
|
7.0 ×10^3 cells/µL
Standard Deviation 1.1
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Total ATP was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Total ATP
|
5.2 µmol/dL
Standard Deviation 1.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Total ATP normalized to platelet count was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Total ATP Normalized to Platelet Count
|
4.3 nmol/×10^8 platelets
Standard Deviation 0.7
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Supernatant LDH activity was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant LDH Activity
|
205 U/L
Standard Deviation 68
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Supernatant LDH normalized to platelet count was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant LDH Normalized to Platelet Count
|
168 U/10^12 platelets
Standard Deviation 54
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Total LDH activity was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Total LDH Activity
|
2534 U/L
Standard Deviation 391
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Supernatant LDH as a % of Total LDH was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Supernatant LDH as a % of Total LDH
|
8.2 Percentage of cell free LDH to total LDH
Standard Deviation 2.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
Baseline Adjusted Supernatant LDH as a % of Total LDH was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: Baseline Adjusted Supernatant LDH as a % of Total LDH
|
2.2 Percentage cell free LDH to Total LDH
Standard Deviation 2.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of storage on Day 5Population: The Per Protocol Set (PPS) included all randomized and infused subjects who have both paired (Test and Control) recovery and paired survival data, Test recovery and survival less than Control recovery and survival and otherwise complied with the protocol without any protocol deviation potentially affecting the primary efficacy outcome . PPS was the primary analysis population for the efficacy evaluation.
P-selectin (CD62P) was summarized descriptively for Test components at end of storage on Day 5
Outcome measures
| Measure |
Test Platelets
n=24 Participants
Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 5 days. Samples from this component were radiolabeled with Variant 1 method.
|
Control Platelets
An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled.
|
|---|---|---|
|
Assessment of Stored Test (INTERCEPT) Platelet Component: P-selectin (CD62P)
|
32.4 percentage of CD62P platelets
Standard Deviation 11.0
|
—
|
Adverse Events
Simultaneous Administration of Test and Control Platelets
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Simultaneous Administration of Test and Control Platelets
n=29 participants at risk
INTERCEPT treated platelets (Test) from 24 healthy subjects, stored for 5 days, will be prepared for radiolabeling following the Variant 1 methodology. The radiolabeled autologous Test and Control platelets, approximately 5 to 30 mL, will be simultaneously administered intravenously into the subject.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection). AEs were collected for the ITT, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
General disorders
Infusion site extravasation
|
3.4%
1/29 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection). AEs were collected for the ITT, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Investigations
Blood creatinine increased
|
3.4%
1/29 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection). AEs were collected for the ITT, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Investigations
Blood glucose increased
|
3.4%
1/29 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection). AEs were collected for the ITT, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Metabolism and nutrition disorders
Citrate toxicity
|
37.9%
11/29 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection). AEs were collected for the ITT, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
1/29 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection). AEs were collected for the ITT, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Skin and subcutaneous tissue disorders
Administration site rash
|
3.4%
1/29 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection). AEs were collected for the ITT, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Vascular disorders
Hematoma
|
17.2%
5/29 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection). AEs were collected for the ITT, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Vascular disorders
Presyncope
|
6.9%
2/29 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection). AEs were collected for the ITT, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
3.4%
1/29 • All AE/SAEs that occur following the start of the apheresis collection through 24 hours and from Day 1 to Day 11 ±1post infusion blood sample (1-3 weeks post collection). AEs were collected for the ITT, comprised of all subjects who initiated an apheresis collection.
An AE is any untoward medical occurrence in a subject or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product whether or not related to the investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sites cannot independently publish data from their site until the combined data from all sites has been published. Cerus must review the proposed publication prior to submission to determine if it contains confidential information.
- Publication restrictions are in place
Restriction type: OTHER