drugset / Trial / NCT04548791
Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of the trial is to evaluate the PK, bioavailability, PD, efficacy and safety of MarzAA for on demand treatment and control of bleeding episodes in adult subjects with inherited bleeding disorders.
Timeline
- Start
- 2021-05-17
- Primary completion
- 2021-11-15
- Completion
- 2021-12-03
Outcome
Outcome not reported
Stopped: “Company decision (not a safety issue)”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MarzAA | Protein / enzyme biologic | 10 ug/kg | Intravenous |
| Subject | MarzAA | Protein / enzyme biologic | 20 ug/kg | Intravenous |
| Subject | MarzAA | Protein / enzyme biologic | 30 ug/kg | Intravenous |
| Subject | MarzAA | Protein / enzyme biologic | 40 ug/kg | Intravenous |
| Subject | MarzAA | Protein / enzyme biologic | 45 ug/kg | Intravenous |
| Subject | MarzAA | Protein / enzyme biologic | 60 ug/kg | Intravenous |
| Subject | MarzAA | Protein / enzyme biologic | 120 ug/kg | Intravenous |
| Subject | MarzAA | Protein / enzyme biologic | 180 ug/kg | Intravenous |