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PK/PD and Safety of Biosimilar Eptacog Alfa (AryoSeven) vs NovoSeven in Hemophilia A or B with Inhibitors
NCT03935334Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2018
- Primary completion
- Jan 2021
- Countries
- 2
- Sponsor
- AryoGen Biopharma
- Modality
- rProtein (Recombinant Protein), Biologic
- Drugs
- AryoSeven
- Conditions
- hemophilia Ahemophilia B (HB)
01
Overview
Phase 3, randomised, double-blind trial of AryoSeven in hemophilia A and hemophilia B (HB) (2 arms), sponsored by AryoGen Biopharma. Primary endpoints: Area under the plasma concentration time curve from time 0 to infinity at 30 hours, Thrombin Generation Assay at 30 hours and 2 more. Started Jul 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sequence A
AryoSeven then NovoSeven
Sequence B
NovoSeven then AryoSeven
03
Endpoints
Primary
Area under the plasma concentration time curve from time 0 to infinity
Thrombin Generation Assay
D-Dimer
Prothrombin fragment 1.2
Secondary
Area under the plasma concentration-time curve from 0 to the last measurable time point
Maximum plasma concentration
Time of Cmax
Fraction of the total AUCinf derived by extrapolation
Terminal rate constant
Elimination half-life
Mean residence time
Clearance
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