24
Participants
Start Date
March 1, 2017
Primary Completion Date
November 30, 2020
Study Completion Date
January 28, 2021
Eptacog alfa, biosimilar
Either a single dose of eptacog alfa biosimilar 30 μg/kg and one single dose of NovoSeven 30 μg/kg, or vice versa, with doses separated by a washout period. Then, in an open follow up phase of 12 months, for every bleeding episode eptacog alfa biosimilar 30 μg/kg, on demand, for one of more days until resolution of bleeding, based on the Investigator's decision - or - prophylaxis with eptacog alfa biosimilar, with dose, frequency, and duration of treatment based on the Investigator's decision. The modality of treatment (on demand or prophylaxis) will be decided by the Investigator.
Novoseven
Either a single dose of eptacog alfa biosimilar 30 μg/kg and one single dose of NovoSeven 30 μg/kg, or vice versa, with doses separated by a washout period.
Hemophilia Center - Hematology & Oncology Dept. Shiraz University of Medical Science, Shiraz
Comprehensive Hemophilia Care Center, Tehran
Lead Sponsor
AryoGen Pharmed Co.
INDUSTRY