Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A
Stopped early · Phase 4
Conditions studied: Hemophilia A
In brief
Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study is to further monitor whether participants with severe Hemophilia A will develop inhibitors or antibodies at the later stage when switched from their current recombinant therapy produced from Chinese Hamster Ovary (CHO) cell line to Kogenate-FS raised in a Baby Hamster Kidney cell line.
Key facts
- Study ID
- NCT00621673
- Run by
- Bayer
- People needed
- 1
- Starts
- 2006-05-01
- Expected to finish
- 2006-10-01
- Last updated by the study team
- 2014-12-18
Who can join
Age: 12 and older, up to 60. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Subjects with severe hemophilia A (< 2% FVIII:C)
- Subjects with no history of FVIII inhibitor antibody formation
- Subjects with no measurable inhibitor activity
- Subjects with at least 200 EDs with FVIII concentrate in total, including 20 EDs in the previous 6 months
- Subjects whose current treatment with any CHO rFVIII product
- Subjects with no elective surgery and/or continuous infusion FVIII administration is foreseen during the study
- Subjects with normal prothrombin time (PT), partial thromboplastin time (PTT) compatible with FVIII deficiency
You may not qualify if…
- Subjects with any other bleeding disease beside hemophilia A (i,e., von Willebrand's disease)
- Subjects who have known intolerance or allergic reactions to constituents of rFVIII-FS or known hypersensitivity to mouse or hamster proteins
- Any individual with a past history of severe reaction(s) to FVIII concentrates
- Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry
- Subjects who were receiving or had received other experimental drugs within 3 months prior to study entry
- Subjects who require any medication for FVIII infusions
Where it is running
- Study site — Detroit, Michigan, United States
- Study site — Las Vegas, Nevada, United States
Full record on ClinicalTrials.gov
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