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Safety and PK of SS109 in Hemophilia Patients With Inhibitors
NCT05651061Phase 1Completed
- Sponsor
- Gensciences
- Start
- Dec 2022
- Primary completion
- Mar 2023
- Modality
- Fc-Fusion Proteins
- Countries
- 1
01
Overview
Phase 1, open-label, single-arm trial of recombinant human coagulation factor VIIa Fc fusion protein in hemophilia A and hemophilia B (HB), sponsored by Gensciences. Primary endpoints: The incidence of adverse event/serious adverse event/special interest adverse event at 28 days and Number of patients with positive FVII inhibitor, anti-drug antibody (ADA) at 28 days. Started Dec 2022; status: completed.
02
Drugs
recombinant human coagulation factor VIIa Fc fusion protein
03
Conditions
hemophilia Ahemophilia B (HB)
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