Status:
COMPLETED
Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B
Lead Sponsor:
Bioverativ Therapeutics Inc.
Collaborating Sponsors:
Swedish Orphan Biovitrum
Conditions:
Hemophilia B
Eligibility:
MALE
Up to 11 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
At the Baseline visit (28 ± 7 days prior to Day 1), participants receive a single IV injection of prestudy FIX over 10 (±5) minutes in the clinic under medical supervision at a dose of 50 IU/kg. A was...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01440946
Start Date
June 1 2012
End Date
November 1 2014
Last Update
December 19 2020
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Phoenix, Arizona, United States
2
Research Site
Sacramento, California, United States
3
Research Site
Atlanta, Georgia, United States
4
Research Site
Honolulu, Hawaii, United States