An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A

Completed · Phase 3

Conditions studied: Hemophilia A

In brief

The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.

Key facts

Study ID

NCT02234323

Run by

Bioverativ, a Sanofi company

People needed

108

Starts

2015-01-12

Expected to finish

2019-09-23

Last updated by the study team

2022-04-11

Who can join

Age: any, up to 5. Sex: male. Healthy volunteers: not accepted.

Where it is running

• Research Site — Duarte, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Torrance, California, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Brewer, Maine, United States
• Research Site — East Lansing, Michigan, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Buffalo, New York, United States
• Research Site — New York, New York, United States
• Research Site — Rochester, New York, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Portland, Oregon, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Dallas, Texas, United States
• Research Site — Dallas, Texas, United States
• Research Site — Milwaukee, Wisconsin, United States
• Research Site — Brisbane, Australia
• Research Site — Parkville, Australia
• Research Site — Perth, Australia
• Research Site — Westmead, Australia
• Research Site — Campinas, Brazil
• Research Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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