Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2008-04-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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rFIXFc
Six intravenous (IV) dose levels, 1, 5, 12.5, 25, 50, and 100 IU/kg
rFIXFc
As specified in the treatment arm
Interventions
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rFIXFc
As specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. No prior history of an allergic reaction or anaphylaxis associated with any FIX or IVIG administration.
4. No concurrent autoimmune disease.
5. At least 7 days since their last dose of FIX (wash-out period).
6. Certain laboratory testing criteria and other protocol-defined criteria may apply.
7. 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.
Exclusion Criteria
2. Any coagulation disorder in addition to hemophilia B.
3. 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.
4. A positive d-dimer at screening.
5. Documented history of liver cirrhosis.
6. 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.
7. Certain prior illnesses and other protocol-defined criteria.
18 Years
MALE
No
Sponsors
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Syntonix Pharmaceuticals, Inc.
INDUSTRY
Swedish Orphan Biovitrum
INDUSTRY
Bioverativ Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Bioverativ Therapeutics Inc.
Locations
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RUSH University Medical Center
Chicago, Illinois, United States
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of North Carolina Medical School
Chapel Hill, North Carolina, United States
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, United States
Puget Sound Blood Center
Seattle, Washington, United States
Countries
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References
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Shapiro AD, Ragni MV, Valentino LA, Key NS, Josephson NC, Powell JS, Cheng G, Thompson AR, Goyal J, Tubridy KL, Peters RT, Dumont JA, Euwart D, Li L, Hallen B, Gozzi P, Bitonti AJ, Jiang H, Luk A, Pierce GF. Recombinant factor IX-Fc fusion protein (rFIXFc) demonstrates safety and prolonged activity in a phase 1/2a study in hemophilia B patients. Blood. 2012 Jan 19;119(3):666-72. doi: 10.1182/blood-2011-07-367003. Epub 2011 Nov 22.
Other Identifiers
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SYN-FIXFc-07-001
Identifier Type: -
Identifier Source: org_study_id