Status:
COMPLETED
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
Lead Sponsor:
Bioverativ Therapeutics Inc.
Collaborating Sponsors:
Swedish Orphan Biovitrum
Conditions:
Hemophilia A
Eligibility:
MALE
Up to 11 years
Phase:
PHASE3
Brief Summary
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 o...
Detailed Description
Previously treated pediatric participants will be treated with a prophylactic regimen of rFVIIIFc. PK analysis of pre-study factor VIII (FVIII) and rFVIIIFc will be performed in a sub-group of the stu...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01458106
Start Date
November 1 2012
End Date
December 1 2013
Last Update
December 19 2020
Active Locations (23)
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1
Research Site
Los Angeles, California, United States
2
Research Site
Sacramento, California, United States
3
Research Site
San Diego, California, United States
4
Research Site
Aurora, Colorado, United States