NCT01458106 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 30, 2012

Primary Completion Date

December 31, 2013

Study Completion Date

December 31, 2013

Conditions

Hemophilia A

Interventions

DRUG

BIIB031 (rFVIIIFc)

Vials of rFVIIIFc were combined as needed, based on the actual labeled potency to achieve the participant's calculated dose. Partial vial use was allowed, in order to achieve the calculated dose.

DRUG

FVIII (PK subgroup only)

Baseline prestudy FVIII dosing in participants who enter the PK subgroup. Vials of prestudy FVIII were combined as needed, based on the nominal labeled potency (e.g., 250 IU, 500 IU, and 1000 IU), to achieve the participant's calculated dose.

Trial Locations (23)

Unknown

Research Site, Los Angeles

Research Site, Sacramento

Research Site, San Diego

Research Site, Aurora

Research Site, Chicago

Research Site, Indianapolis

Research Site, St Louis

Research Site, Las Vegas

Research Site, Cincinnati

Research Site, Columbus

Research Site, Portland

Research Site, Pittsburgh

Research Site, Brisbane

Research Site, Melbourne

Research Site, Hong Kong

Research Site, Dublin

Research Site, Groningen

Research Site, Lublin

Research Site, Johannesburg

Research Site, Cambridge

Research Site, Basingstoke

Research Site, Glasgow

Research Site, London