Trial Outcomes & Findings for Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults (NCT NCT04593784)
NCT ID: NCT04593784
Last Updated: 2026-04-20
Results Overview
The primary efficacy endpoint is achieving a WBCT (measured by PoC coagulometer) ≤ 120% of baseline within 1 hour after administration of ciraparantag/PBO, which is subsequently sustained after 1 hour through at least 6 hours after ciraparantag/PBO dosing (Responder).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Within 1 hour and sustained through 6 hours
Results posted on
2026-04-20
Participant Flow
Screening occurred between Oct 2021 and Aug 2023 at 3 phase 1 clinics. Subjects were enrolled into the cohorts listed below (i.e., no participants were enrolled in Cohort 2, Apixaban 10mg).
41 subjects were enrolled; 40 subjects were assigned to a cohort (1 subject discontinued due to cohort being full). Of the 40 subjects assigned to a cohort and dosed with anticoagulant, 37 subjects were randomized and 3 subjects were not randomized and discontinued the study early, prior to treatment with ciraparantag/placebo, due to not meeting study WBCT threshold for sufficient anticoagulation.
Participant milestones
| Measure |
Cohort 1 (Edox) PBO
Subjects received 60 mg edoxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last edoxaban dose, a single IV dose of placebo was administered.
|
Cohort 1 (Edox) Cira 180 mg
Subjects received 60 mg edoxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last edoxaban dose, a single IV dose of 180 mg ciraparantag was administered.
|
Cohort 3 (Riva) Cira 180 mg
Subjects receive 20 mg rivaroxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last rivaroxaban dose, a single IV dose of 180 mg ciraparantag was administered.
|
Cohort 3 (Riva) PBO
Subjects receive 20 mg rivaroxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last rivaroxaban dose, a single IV dose of placebo was administered.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
12
|
13
|
6
|
|
Overall Study
COMPLETED
|
6
|
12
|
12
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 (Edox) PBO
Subjects received 60 mg edoxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last edoxaban dose, a single IV dose of placebo was administered.
|
Cohort 1 (Edox) Cira 180 mg
Subjects received 60 mg edoxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last edoxaban dose, a single IV dose of 180 mg ciraparantag was administered.
|
Cohort 3 (Riva) Cira 180 mg
Subjects receive 20 mg rivaroxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last rivaroxaban dose, a single IV dose of 180 mg ciraparantag was administered.
|
Cohort 3 (Riva) PBO
Subjects receive 20 mg rivaroxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last rivaroxaban dose, a single IV dose of placebo was administered.
|
|---|---|---|---|---|
|
Overall Study
Randomized, not dosed w ciraparantag, due to not meeting threshold for sufficient anticoagulation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults
Baseline characteristics by cohort
| Measure |
Cohort 1 (Edox) PBO
n=6 Participants
Subjects received 60 mg edoxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last edoxaban dose, a single IV dose of placebo was administered.
|
Cohort 1 (Edox) Cira 180 mg
n=12 Participants
Subjects received 60 mg edoxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last edoxaban dose, a single IV dose of 180 mg ciraparantag was administered.
|
Cohort 3 (Riva) PBO
n=6 Participants
Subjects receive 20 mg rivaroxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last rivaroxaban dose, a single IV dose of placebo was administered.
|
Cohort 3 (Riva) Cira 180 mg
n=12 Participants
Subjects receive 20 mg rivaroxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last rivaroxaban dose, a single IV dose of 180 mg ciraparantag was administered.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.7 Years
STANDARD_DEVIATION 15.38 • n=129 Participants
|
45.3 Years
STANDARD_DEVIATION 14.46 • n=22 Participants
|
43.5 Years
STANDARD_DEVIATION 15.6 • n=151 Participants
|
47.0 Years
STANDARD_DEVIATION 14.76 • n=94 Participants
|
45.4 Years
STANDARD_DEVIATION 14.30 • n=25 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=129 Participants
|
7 Participants
n=22 Participants
|
1 Participants
n=151 Participants
|
4 Participants
n=94 Participants
|
13 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=129 Participants
|
5 Participants
n=22 Participants
|
5 Participants
n=151 Participants
|
8 Participants
n=94 Participants
|
23 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=129 Participants
|
7 Participants
n=22 Participants
|
1 Participants
n=151 Participants
|
6 Participants
n=94 Participants
|
17 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=129 Participants
|
5 Participants
n=22 Participants
|
5 Participants
n=151 Participants
|
6 Participants
n=94 Participants
|
19 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=129 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=129 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=129 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=94 Participants
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=129 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=129 Participants
|
2 Participants
n=22 Participants
|
4 Participants
n=151 Participants
|
1 Participants
n=94 Participants
|
8 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=129 Participants
|
9 Participants
n=22 Participants
|
2 Participants
n=151 Participants
|
11 Participants
n=94 Participants
|
27 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=129 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=129 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=151 Participants
|
0 Participants
n=94 Participants
|
0 Participants
n=25 Participants
|
|
Baseline Whole Blood Clotting Time (WBCT) as measured by PoC Coagulometer
|
235.2 seconds
STANDARD_DEVIATION 37.69 • n=129 Participants
|
239.0 seconds
STANDARD_DEVIATION 35.76 • n=22 Participants
|
213.7 seconds
STANDARD_DEVIATION 30.85 • n=151 Participants
|
235.4 seconds
STANDARD_DEVIATION 28.52 • n=94 Participants
|
232.9 seconds
STANDARD_DEVIATION 32.80 • n=25 Participants
|
PRIMARY outcome
Timeframe: Within 1 hour and sustained through 6 hoursPopulation: The Efficacy Population included those randomized subjects who received the planned single dose of ciraparantag/PBO and had at least one subsequent WBCT (as measured by PoC coagulometer) measurement. Subjects were analyzed based on their randomized treatment assignment.
The primary efficacy endpoint is achieving a WBCT (measured by PoC coagulometer) ≤ 120% of baseline within 1 hour after administration of ciraparantag/PBO, which is subsequently sustained after 1 hour through at least 6 hours after ciraparantag/PBO dosing (Responder).
Outcome measures
| Measure |
Cohort 1 (Edox) Cira 180 mg
n=12 Participants
Subjects received 60 mg edoxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last edoxaban dose, a single IV dose of 180 mg ciraparantag was administered.
|
Cohort 1 (Edox) PBO
n=6 Participants
Subjects received 60 mg edoxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last edoxaban dose, a single IV dose of placebo was administered.
|
Cohort 3 (Riva) Cira 180 mg
n=12 Participants
Subjects receive 20 mg rivaroxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last rivaroxaban dose, a single IV dose of 180 mg ciraparantag was administered.
|
Cohort 3 (Riva) PBO
n=6 Participants
Subjects receive 20 mg rivaroxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last rivaroxaban dose, a single IV dose of placebo was administered.
|
|---|---|---|---|---|
|
Subjects Achieving WBCT ≤120% of Baseline
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1 (Edox) PBO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3 (Riva) PBO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 1 (Edox) Cira 180 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 3 (Riva) Cira 180 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Enrolled Not Treated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 (Edox) PBO
n=6 participants at risk
Subjects received 60 mg edoxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last edoxaban dose, a single IV dose of placebo was administered.
|
Cohort 3 (Riva) PBO
n=6 participants at risk
Subjects receive 20 mg rivaroxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last rivaroxaban dose, a single IV dose of placebo was administered.
|
Cohort 1 (Edox) Cira 180 mg
n=12 participants at risk
Subjects received 60 mg edoxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last edoxaban dose, a single IV dose of 180 mg ciraparantag was administered.
|
Cohort 3 (Riva) Cira 180 mg
n=12 participants at risk
Subjects receive 20 mg rivaroxaban orally once daily in the morning from Day 1 to Day 3 or Day 4. On Day 3 / 4, approximately 3 hours after the last rivaroxaban dose, a single IV dose of 180 mg ciraparantag was administered.
|
Enrolled Not Treated
n=4 participants at risk
Subjects received 60 mg edoxaban or 20 mg rivaroxaban orally once daily in the morning from Day 1 up to Day 3 or Day 4. Subjects discontinued the study early (prior to treatment with ciraparantag/placebo) due to not meeting study WBCT threshold for sufficient anticoagulation.
|
|---|---|---|---|---|---|
|
General disorders
Feeling Hot
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
16.7%
2/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
25.0%
3/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/4 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
|
General disorders
Infusion site erythema
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
8.3%
1/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/4 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
8.3%
1/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/4 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
8.3%
1/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/4 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
8.3%
1/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/4 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
8.3%
1/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/4 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
8.3%
1/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/4 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
8.3%
1/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/4 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
8.3%
1/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/4 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/6 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
8.3%
1/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/12 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
0.00%
0/4 • Adverse events were monitored from the time the informed consent was signed through the last study visit / study completion which occurred five days after IP-dosing. Serious Adverse Events were reported through 30 days after the last dose of ciraparantag/placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication based on the results obtained at the Site shall not be made before the first multi-centre publication. The INVESTIGATOR shall have publication or presentation privileges provided manuscript/abstract is submitted to SPONSOR for review/comment sixty (60) days prior to submission; INSTITUTION agrees to delete information identified by CRO/SPONSOR as Confidential Information.
- Publication restrictions are in place
Restriction type: OTHER