Last updated on October 2018

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


Brief description of study

The primary objective of the study is to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants with severe hemophilia A. The secondary objectives are to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in previously untreated patients (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.

Clinical Study Identifier: NCT02234323

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Little Rock, AR United States

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Duarte, CA United States

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Sacramento, CA United States

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San Francisco, CA United States

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Torrance, CA United States

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Indianapolis, IN United States

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Louisville, KY United States

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Brewer, ME United States

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East Lansing, MI United States

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Minneapolis, MN United States

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Saint Louis, MO United States

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Buffalo, NY United States

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New York, NY United States

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Rochester, NY United States

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Columbus, OH United States

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Portland, OR United States

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Philadelphia, PA United States

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Dallas, TX United States

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Milwaukee, WI United States

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Brisbane, Australia

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Parkville, Australia

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Perth, Australia

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Westmead, Australia

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Campinas, Brazil

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Canoas, Brazil

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Rio de Janeiro, Brazil

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Hamilton, Canada

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London, Canada

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Toronto, Canada

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Caen cedex 9, France

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Lille Cedex, France

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Nantes Cedex 1, France

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Strasbourg, France

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Toulouse cedex, France

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Tours cedex 9, France

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Bonn, Germany

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Duesseldorf, Germany

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Frankfurt, Germany

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Dublin, Ireland

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Vicenza, Italy

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Bari, Italy

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Florence, Italy

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Genova, Italy

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Milan, Italy

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Napoli, Italy

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Padova, Italy

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Rome, Italy

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Leiden, Netherlands

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Utrecht, Netherlands

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Auckland, New Zealand

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Christchurch, New Zealand

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Gdansk, Poland

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Lublin, Poland

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Warszawa, Poland

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Barcelona, Spain

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Madrid, Spain

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Stockholm, Sweden

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Cambridge, United Kingdom

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Basingstoke, United Kingdom

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Whitechapel, United Kingdom

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Cardiff, United Kingdom

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Sheffield, United Kingdom

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Ribeirão Preto, Brazil

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São Paulo, Brazil

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Le Kremlin Bicêtre cedex, France

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Berlin, Germany

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Hannöver, Germany

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Kraków, Poland

Recruitment Status: Closed


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