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

NCT01440946

CompletedPhase 3

Sponsor: Bioverativ Therapeutics Inc.

Conditions: Hemophilia B

Interventions: rFIXFc, FIX

Countries: United States, Australia, Ireland, Netherlands, South Africa, United Kingdom

The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia B. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFIXFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFIXFc; to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes

Eligibility overview

Sex: MALE

Age: — to 11 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

* Severe hemophilia B defined as ≤ 2 IU/dl (≤ 2%) endogenous FIX
* Male \< 12 years and weight ≥ 13 kg
* History of at least 50 documented prior exposure days to FIX
* No history of, or currently detectable, inhibitor

Key Exclusion Criteria:

* Other coagulation disorders in addition to Hemophilia B
* History of anaphylaxis associated with any FIX or IV immunoglobulin administration

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Locations (15)

Phoenix, Arizona, United States
Sacramento, California, United States
Atlanta, Georgia, United States
Honolulu, Hawaii, United States
Indianapolis, Indiana, United States
East Lansing, Michigan, United States
Pittsburgh, Pennsylvania, United States
Parkville, Victoria, Australia
Subiaco, Western Australia, Australia
Dublin, Ireland
Utrecht, Netherlands
Johannesburg, South Africa
Basingstoke, United Kingdom
Cambridge, United Kingdom
London, United Kingdom