Status:
TERMINATED
Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
MALE
12-60 years
Phase:
PHASE4
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00621673
Start Date
May 1 2006
End Date
October 1 2006
Last Update
December 18 2014
Active Locations (2)
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1
Detroit, Michigan, United States, 48202
2
Las Vegas, Nevada, United States, 89109