Overview

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

Status:
Completed

Trial end date:
2013-12-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 3

Details

Lead Sponsor:

Biogen
Bioverativ Therapeutics Inc.

Collaborator:

Swedish Orphan Biovitrum

Treatments:

Factor VIII
Immunoglobulin Fc Fragments