Study Comparing the Pharmacokinetic of Biosimilar Eptacog Alfa With Novoseven®, in Patients With Congenital Factor VII Deficiency

PHASE3CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 1, 2017

Primary Completion Date

November 30, 2020

Study Completion Date

January 28, 2021

Conditions
Factor VII Deficiency
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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.

Trial Locations (2)

Unknown

Hemophilia Center - Hematology & Oncology Dept. Shiraz University of Medical Science, Shiraz

Comprehensive Hemophilia Care Center, Tehran

Sponsors
All Listed Sponsors
lead

AryoGen Pharmed Co.

INDUSTRY