Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A

Completed · Phase 3

Conditions studied: Hemophilia A

In brief

The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc consumption for prevention and treatment of bleeding episodes.

Key facts

Study ID
NCT01458106
Run by
Bioverativ Therapeutics Inc.
People needed
71
Starts
2012-11-01
Expected to finish
2013-12-01
Last updated by the study team
2020-12-19

Who can join

Age: any, up to 11. Sex: male. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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