Status:
COMPLETED
Combination Therapy of Low Doses of rFVIIa and FEIBA for Severe Hemophilia A Patients With an Inhibitor to Factor VIII
Lead Sponsor:
Sheba Medical Center
Conditions:
Hemophilia A
Eligibility:
MALE
16-65 years
Phase:
PHASE4
Brief Summary
Patients with severe hemophilia and inhibitors can be treated effectively by Activated Prothrombin Complex Concentrates (APCC, eg. FEIBA) or High dose recombinant factor VIIa (rFVIIa). Rarely, such pa...
Detailed Description
Inhibitor patients with HR inhibitors were eligible for study enrollment. After consent blood was drawn and ex- vivo spiked with rFVIIa/FEIBA and combinations, assayed by thrombin generation tests. T...
Eligibility Criteria
Inclusion
- Hemophilia patients with inhibitors
- Patients signing informed consent
Exclusion
- Patients under 16 or above 65
- Patients with allergic reaction or adverse events in previous use the concentrates
- Patients with high risk of thrombosis
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00284193
Start Date
January 1 2005
End Date
November 1 2009
Last Update
July 27 2012
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