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AryoSeven versus NovoSeven bioequivalence study in hemophilia with inhibitors
IRCT2017021831193N2Phase 3Completed
- Sponsor
- AryoGen Biopharma
- Start
- Sep 2018
- Modality
- Recombinant Proteins and Enzymes
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial of AryoSeven and coagulation factor VIIa in hemophilia A and hemophilia B (HB) (2 arms), sponsored by AryoGen Biopharma. Primary endpoints: Area under the concentration-time curve extrapolated to infinity, Thrombin generation assay and 2 more. Started Sep 2018; status: completed.
02
Drugs
AryoSevencoagulation factor VIIa
03
Conditions
hemophilia Ahemophilia B (HB)
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