drugset / Trial / NCT03407651
Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B
Non-randomizedSequentialOpen-labelTreatment
Summary
Phase 2, multi-center, open-label study designed to evaluate the PK, bioavailability, PD, efficacy and safety of a daily subcutaneous \[SC\] treatment regimen with MarzAA for bleeding prophylaxis in 12 adult subjects with hemophilia A or B with an inhibitor and history of frequent spontaneous bleeding episodes.
Timeline
- Start
- 2017-12-18
- Primary completion
- 2019-03-15
- Completion
- 2019-04-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Marzeptacog Alfa (Activated) | Protein / enzyme biologic | 18 ug/kg | Intravenous |
| Subject | Marzeptacog Alfa (Activated) | Protein / enzyme biologic | 30 ug/kg | Intravenous |
| Subject | Marzeptacog Alfa (Activated) | Protein / enzyme biologic | 60 ug/kg | Intravenous |
| Subject | Marzeptacog Alfa (Activated) | Protein / enzyme biologic | 90 ug/kg | Intravenous |
| Subject | Marzeptacog Alfa (Activated) | Protein / enzyme biologic | 120 ug/kg | Intravenous |