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Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B — PUPs B-LONG  

Hemophilia B Clinical Trial

Official title:
An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc; BIIB029) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia B

Clinical Trial Summary

The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B. Secondary objectives were to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes in PUPs, and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in PUPs.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02234310
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date November 13, 2014
Completion date August 20, 2019
View Details
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