Status:
TERMINATED
BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
MALE
12-70 years
Phase:
PHASE2
Brief Summary
A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in su...
Eligibility Criteria
Inclusion
- Males aged 12 to 70 years
- Subjects with severe hemophilia A (\< 1% factor VIII \[FVIII\]:C)
- Subjects with equal or greater than 150 exposure days (EDs) with any FVIII in total
- Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule
- Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records
- Subjects with no measurable inhibitor activity
- Subjects with no history of FVIII inhibitor antibody formation
- Written informed consent by subject and parent / legal representative, if \< 18 years
Exclusion
- Subjects who are receiving primary prophylaxis
- Subjects on prophylaxis with documented requirements of \> 75 IU/kg/week
- Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)
- Subjects with abnormal renal function
- Subjects with elevated hepatic transaminases
- Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study
- Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG)
- Subjects who require any pre-medication for FVIII injections
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00623727
Start Date
June 1 2008
End Date
October 1 2010
Last Update
July 15 2013
Active Locations (95)
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1
Orange, California, United States, 92868
2
Sacramento, California, United States, 95817
3
San Francisco, California, United States, 94143-0324
4
Aurora, Colorado, United States, 80045