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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
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

NCT01458106

CompletedPhase 3

Sponsor: Bioverativ Therapeutics Inc.

Conditions: Hemophilia A

Interventions: BIIB031 (rFVIIIFc), FVIII (PK subgroup only)

Countries: United States, Australia, Hong Kong, Ireland, Netherlands, Poland, South Africa, United Kingdom

The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc 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 A defined as \<1 IU/dL (\<1%) endogenous FVIII
* Male \<12 years of age and weight ≥13 kg
* History of at least 50 documented prior exposure days to FVIII
* No current, or history of, inhibitor development to FVIII

Key Exclusion Criteria:

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

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Locations (23)
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • Aurora, Colorado, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • Cincinnati, Ohio, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Pittsburgh, Pennsylvania, United States
  • Brisbane, Queensland, Australia
  • Melbourne, Victoria, Australia
  • Hong Kong, Hong Kong
  • Dublin, Ireland
  • Groningen, Netherlands
  • Lublin, Poland
  • Johannesburg, South Africa
  • Cambridge, Cambridgshire, United Kingdom
  • Basingstoke, Hampshire, United Kingdom
  • Glasgow, United Kingdom
  • London, United Kingdom