Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B

PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Hemophilia B
Interventions
DRUG

rFIXFc

Vials of rFIXFc 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

FIX

Vials of prestudy FIX (provided by the participants) 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 (15)

Unknown

Research Site, Phoenix

Research Site, Sacramento

Research Site, Atlanta

Research Site, Honolulu

Research Site, Indianapolis

Research Site, East Lansing

Research Site, Pittsburgh

Research Site, Parkville

Research Site, Subiaco

Research Site, Dublin

Research Site, Utrecht

Research Site, Johannesburg

Research Site, Basingstoke

Research Site, Cambridge

Research Site, London

Sponsors
All Listed Sponsors
collaborator

Swedish Orphan Biovitrum

INDUSTRY

lead

Bioverativ Therapeutics Inc.

INDUSTRY