Status:
COMPLETED
Phase I/IIa Study of FIXFc in Hemophilia B Patients
Lead Sponsor:
Bioverativ Therapeutics Inc.
Collaborating Sponsors:
Syntonix Pharmaceuticals, Inc.
Swedish Orphan Biovitrum
Conditions:
Hemophilia B
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of the study is to assess safety of FIXFc at doses ranging from 1 to 100 IU/kg.
Detailed Description
This study was previously posted by Syntonix Pharmaceuticals, Inc. In January, 2007, sponsorship of the trial was transferred to Biogen Idec. In February, 2017, sponsorship of the trial was transferre...
Eligibility Criteria
Inclusion
- Key
- Are previously treated (PTPs) with severe (\<2 IU/dL endogenous FIX level) hemophilia B and at least 150 prior documented exposure days to other FIX products.
- Have no prior history of or currently detectable inhibitor defined as \> 0.6 Bethesda units by the local lab. A family history of inhibitors will not exclude the patient.
- No prior history of an allergic reaction or anaphylaxis associated with any FIX or IVIG administration.
- No concurrent autoimmune disease.
- At least 7 days since their last dose of FIX (wash-out period).
- Certain laboratory testing criteria and other protocol-defined criteria may apply.
- HIV negative or if HIV positive with a CD4 count ≥ 200 cells/mm3. HIV patients are allowed to receive protease inhibitors per the discretion of the Investigator.
- Key
Exclusion
- Presence of a major bleeding episode on Day 1 of study.
- Any coagulation disorder in addition to hemophilia B.
- A patient currently on a dose and regimen of FIX that would preclude participation in the study due to possible increased risk of bleeding because of the requirement to withhold treatment during the study period.
- A positive d-dimer at screening.
- Documented history of liver cirrhosis.
- Positive for HBsAg and/or positive for hepatitis C antibody, and/or HIV positive with an ALT or AST greater than 5 times upper limit of normal.
- Certain prior illnesses and other protocol-defined criteria.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00716716
Start Date
April 1 2008
End Date
October 1 2009
Last Update
December 19 2020
Active Locations (6)
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1
RUSH University Medical Center
Chicago, Illinois, United States, 60612
2
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States, 46260
3
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
4
University of North Carolina Medical School
Chapel Hill, North Carolina, United States, 27599