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Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A
Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A

NCT01181128

CompletedPhase 3

Sponsor: Bioverativ Therapeutics Inc.

Conditions: Severe Hemophilia A

Interventions: Factor VIII (rFVIIIFc), Advate®

Countries: United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany

The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.

Eligibility overview

Sex: MALE

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Male, ≥12 years of age with weight at least 40 kg
* Diagnosed with severe hemophilia A, defined as \<1 IU/dL (\<1%) endogenous Factor VIII)
* History of at least 150 documented prior exposure days to any Factor VIII product
* Platelet count ≥100,000 cells/μL

Exclusion Criteria:

* History of Factor VIII inhibitors
* Kidney and liver dysfunction
* Diagnosed with other coagulation disorder(s) in addition to hemophilia A
* Prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration
Locations (64)
  • Little Rock, Arkansas, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • Washington D.C., District of Columbia, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Louisville, Kentucky, United States
  • New Orleans, Louisiana, United States
  • Boston, Massachusetts, United States
  • East Lansing, Michigan, United States
  • Las Vegas, Nevada, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Philadelphia, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Seattle, Washington, United States
  • Camperdown, New South Wales, Australia
  • Adelaide, South Australia, Australia
  • Perth, Western Australia, Australia
  • Vienna, Austria
  • Brussels, Belgium
  • Campinas, Brazil
  • Calgary, Canada
  • Toronto, Canada
  • Vancouver, Canada
  • + 34 more on CT.gov