Trial Outcomes & Findings for A Study in Healthy Men to Compare 2 Different Formulations of Alteplase (NCT NCT04419493)
NCT ID: NCT04419493
Last Updated: 2023-04-26
Results Overview
The area under the concentration-time curve of alteplase in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
Results posted on
2023-04-26
Participant Flow
This was a randomised, open-label, 2 -way cross-over design with at least 24 h wash-out, to establish the bioequivalence of alteplase derived from two different manufacturing processes (new process, tissue plasminogen activator (TPA)-05, vs. current process, TPA-02) in healthy male volunteers.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. In this cross-over trial 2 single doses of alteplase were infused on 2 consecutive days keeping a wash-out period of at least 24 h.
Participant milestones
| Measure |
Part A: Alteplase, TPA-02 Then Alteplase, TPA-05
Participants were administered on Day 1 of Period 1 a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 minutes (min) infusion.
On Day 1 of Period 2 participants were administered a single dose of 0.2 mg/kg body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 min infusion.
The 2 treatment periods were separated by a washout period of at least 24 hours (h).
|
Part A: Alteplase, TPA-05 Then Alteplase, TPA-02
Participants were administered on Day 1 of Period 1 a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 minutes (min) infusion.
On Day 1 of Period 2 participants were administered a single dose of 0.2 mg/kg body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 min infusion.
The 2 treatment periods were separated by a washout period of at least 24 hours (h).
|
Part B: Alteplase, TPA-02 Then Alteplase, TPA-05
Participants were administered on Day 1 of Period 1 a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 minutes (min) infusion. 5 min prior to the infusion of alteplase, TPA-02, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
On Day 1 of Period 2 participants were administered a single dose of 0.2 mg/kg body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 min infusion. 5 min prior to the infusion of alteplase, TPA-05, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
The 2 treatment periods were separated by a washout period of at least 24 hours (h).
|
Part B: Alteplase, TPA-05 Then Alteplase, TPA-02
Participants were administered on Day 1 of Period 1 a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 minutes (min) infusion. 5 min prior to the infusion of alteplase, TPA-05, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
On Day 1 of Period 2 participants were administered a single dose of 0.2 mg/kg body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 min infusion. 5 min prior to the infusion of alteplase, TPA-02, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
The 2 treatment periods were separated by a washout period of at least 24 hours (h).
|
|---|---|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
9
|
9
|
|
Period 1
COMPLETED
|
6
|
6
|
9
|
9
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Wash-out After Period 1
STARTED
|
6
|
6
|
9
|
9
|
|
Wash-out After Period 1
COMPLETED
|
5
|
4
|
8
|
9
|
|
Wash-out After Period 1
NOT COMPLETED
|
1
|
2
|
1
|
0
|
|
Period 2
STARTED
|
5
|
4
|
8
|
9
|
|
Period 2
COMPLETED
|
5
|
4
|
8
|
9
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: Alteplase, TPA-02 Then Alteplase, TPA-05
Participants were administered on Day 1 of Period 1 a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 minutes (min) infusion.
On Day 1 of Period 2 participants were administered a single dose of 0.2 mg/kg body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 min infusion.
The 2 treatment periods were separated by a washout period of at least 24 hours (h).
|
Part A: Alteplase, TPA-05 Then Alteplase, TPA-02
Participants were administered on Day 1 of Period 1 a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 minutes (min) infusion.
On Day 1 of Period 2 participants were administered a single dose of 0.2 mg/kg body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 min infusion.
The 2 treatment periods were separated by a washout period of at least 24 hours (h).
|
Part B: Alteplase, TPA-02 Then Alteplase, TPA-05
Participants were administered on Day 1 of Period 1 a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 minutes (min) infusion. 5 min prior to the infusion of alteplase, TPA-02, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
On Day 1 of Period 2 participants were administered a single dose of 0.2 mg/kg body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 min infusion. 5 min prior to the infusion of alteplase, TPA-05, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
The 2 treatment periods were separated by a washout period of at least 24 hours (h).
|
Part B: Alteplase, TPA-05 Then Alteplase, TPA-02
Participants were administered on Day 1 of Period 1 a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 minutes (min) infusion. 5 min prior to the infusion of alteplase, TPA-05, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
On Day 1 of Period 2 participants were administered a single dose of 0.2 mg/kg body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 min infusion. 5 min prior to the infusion of alteplase, TPA-02, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
The 2 treatment periods were separated by a washout period of at least 24 hours (h).
|
|---|---|---|---|---|
|
Wash-out After Period 1
Adverse Event
|
1
|
2
|
1
|
0
|
Baseline Characteristics
A Study in Healthy Men to Compare 2 Different Formulations of Alteplase
Baseline characteristics by cohort
| Measure |
Part A: Alteplase, TPA-02 Then Alteplase, TPA-05
n=6 Participants
Participants were administered on Day 1 of Period 1 a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 minutes (min) infusion.
On Day 1 of Period 2 participants were administered a single dose of 0.2 mg/kg body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 min infusion.
The 2 treatment periods were separated by a washout period of at least 24 hours (h).
|
Part A: Alteplase, TPA-05 Then Alteplase, TPA-02
n=6 Participants
Participants were administered on Day 1 of Period 1 a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 minutes (min) infusion.
On Day 1 of Period 2 participants were administered a single dose of 0.2 mg/kg body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 min infusion.
The 2 treatment periods were separated by a washout period of at least 24 hours (h).
|
Part B: Alteplase, TPA-02 Then Alteplase, TPA-05
n=9 Participants
Participants were administered on Day 1 of Period 1 a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 minutes (min) infusion. 5 min prior to the infusion of alteplase, TPA-02, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
On Day 1 of Period 2 participants were administered a single dose of 0.2 mg/kg body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 min infusion. 5 min prior to the infusion of alteplase, TPA-05, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
The 2 treatment periods were separated by a washout period of at least 24 hours (h).
|
Part B: Alteplase, TPA-05 Then Alteplase, TPA-02
n=9 Participants
Participants were administered on Day 1 of Period 1 a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 minutes (min) infusion. 5 min prior to the infusion of alteplase, TPA-05, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
On Day 1 of Period 2 participants were administered a single dose of 0.2 mg/kg body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 min infusion. 5 min prior to the infusion of alteplase, TPA-02, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
The 2 treatment periods were separated by a washout period of at least 24 hours (h).
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.3 Years
STANDARD_DEVIATION 5.8 • n=99 Participants
|
32.2 Years
STANDARD_DEVIATION 6.2 • n=107 Participants
|
31.7 Years
STANDARD_DEVIATION 5.8 • n=206 Participants
|
35.8 Years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
33.5 Years
STANDARD_DEVIATION 5.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.Population: Pharmacokinetic parameter analysis set - part A (PKS-A): Includes all subjects in the treated set - part A (TS-A) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol violation to the evaluation of PK or due to PK non-evaluability. PK data for Part A were not used for the final assessment of bioequivalence according to protocol amendment after obtaining unreliable PK results.
The area under the concentration-time curve of alteplase in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.Population: Pharmacokinetic parameter analysis set - part B(PKS-B): This set includes all subjects in the treated set - part B (TS-B) who provide at least one Pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.
The area under the concentration-time curve of Alteplase in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.
Outcome measures
| Measure |
Part A: Alteplase, TPA -02
n=16 Participants
Participants were administered during trial Part A a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 minutes (min) infusion.
|
Part A: Alteplase, TPA-05
n=16 Participants
Participants were administered during trial Part B a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 minutes (min) infusion.
|
|---|---|---|
|
Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz)
|
369.21 hour * nanogram / milliliter (h*ng/mL)
Standard Error NA
The standard error is actually adjusted standard error and is equal to 1.03.
|
377.35 hour * nanogram / milliliter (h*ng/mL)
Standard Error NA
The standard error is actually adjusted standard error and is equal to 1.03.
|
PRIMARY outcome
Timeframe: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.Population: Pharmacokinetic parameter analysis set - part A (PKS-A): Includes all subjects in the treated set - part A (TS-A) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol violation to the evaluation of PK or due to PK non-evaluability. PK data for Part A were not used for the final assessment of bioequivalence according to protocol amendment after obtaining unreliable PK results.
Maximum measured concentration of alteplase in plasma is reported.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.Population: Pharmacokinetic parameter analysis set - part B(PKS-B): This set includes all subjects in the treated set - part B (TS-B) who provide at least one Pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.
Maximum measured concentration of Alteplase in plasma (Cmax) is reported.
Outcome measures
| Measure |
Part A: Alteplase, TPA -02
n=16 Participants
Participants were administered during trial Part A a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 minutes (min) infusion.
|
Part A: Alteplase, TPA-05
n=16 Participants
Participants were administered during trial Part B a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 minutes (min) infusion.
|
|---|---|---|
|
Part B: Maximum Measured Concentration of Alteplase in Plasma (Cmax)
|
738.35 nanogram / milliliter (ng/mL)
Standard Error NA
The standard error is actually adjusted standard error and is equal to 1.02.
|
781.24 nanogram / milliliter (ng/mL)
Standard Error NA
The standard error is actually adjusted standard error and is equal to 1.02.
|
SECONDARY outcome
Timeframe: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.Population: Pharmacokinetic parameter analysis set - part A (PKS-A): Includes all subjects in the treated set - part A (TS-A) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol violation to the evaluation of PK or due to PK non-evaluability. PK data for Part A were not used for the final assessment of bioequivalence according to protocol amendment after obtaining unreliable PK results.
Area under the concentration-time curve of alteplase in plasma over interval from 0 extrapolated to infinity is reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.Population: Pharmacokinetic parameter analysis set - part B(PKS-B): This set includes all subjects in the treated set - part B (TS-B) who provide at least one Pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.
Area under the concentration-time curve of alteplase in plasma over the interval from 0 extrapolated to infinity is reported.
Outcome measures
| Measure |
Part A: Alteplase, TPA -02
n=16 Participants
Participants were administered during trial Part A a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 minutes (min) infusion.
|
Part A: Alteplase, TPA-05
n=16 Participants
Participants were administered during trial Part B a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 minutes (min) infusion.
|
|---|---|---|
|
Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Interval From 0 Extrapolated to Infinity (AUC0-∞)
|
371.85 hour*nanogram/milliliter (h*ng/mL)
Standard Error NA
The standard error is actually adjusted standard error and is equal to 1.03.
|
379.90 hour*nanogram/milliliter (h*ng/mL)
Standard Error NA
The standard error is actually adjusted standard error and is equal to 1.03.
|
Adverse Events
Part A: Alteplase, TPA-02
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Alteplase, TPA-02
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part A: Alteplase, TPA-05
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B: Alteplase, TPA-05
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Alteplase, TPA-02
n=10 participants at risk
Participants were administered during trial Part A a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 minutes (min) infusion.
|
Part B: Alteplase, TPA-02
n=18 participants at risk
Participants were administered during trial Part B a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from current manufacturing process (alteplase, TPA-02) intravenously (i.v.) over a 30 minutes (min) infusion. 5 min prior to the infusion of alteplase, TPA-02, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
|
Part A: Alteplase, TPA-05
n=11 participants at risk
Participants were administered during trial Part A a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 minutes (min) infusion.
|
Part B: Alteplase, TPA-05
n=17 participants at risk
Participants were administered during trial Part B a single dose of 0.2 milligram (mg)/kilogram (kg) body weight of alteplase from modified manufacturing process (alteplase, TPA-05) intravenously (i.v.) over a 30 minutes (min) infusion. 5 min prior to the infusion of alteplase, TPA-05, participants were administered 5000 international units (IU) of the auxiliary medicinal product (AMP) unfractionated heparin (Heparin-Natrium-ratiopharm®) as an intravenous bolus.
|
|---|---|---|---|---|
|
General disorders
Catheter site paraesthesia
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
9.1%
1/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
General disorders
Catheter site swelling
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.6%
1/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
9.1%
1/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.9%
1/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
9.1%
1/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.9%
1/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
11.8%
2/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
11.1%
2/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
General disorders
Infusion site pain
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.6%
1/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.9%
1/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.9%
1/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.6%
1/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.9%
1/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle discomfort
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.6%
1/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.6%
1/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.6%
1/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.6%
1/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.6%
1/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.6%
1/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
|
Product Issues
Device occlusion
|
10.0%
1/10 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
0.00%
0/18 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
18.2%
2/11 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
5.9%
1/17 • Up to 22 days after the last administration of alteplase.
Treated set - part A (TS-A) and Treated set - part B (TS-B): The treated sets includes all subjects who were randomized and treated with at least one dose of study drug.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place