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Sponsored by: |
Sheba Medical Center |
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Information provided by: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT00284193 |
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 patients develop refractoriness to these products for whom therapy with sequential FEIBA and rFVIIa has been recently suggested.
The impetus for the present report was a hemophilia A patient with high titer inhibitor (1300BU) who had life threatening hematuria that was resistant to repeated doses of 400µg/kg rFVIIa up to a cumulative dose of 1200 µg/kg given over 6-9 hours.
Thrombin generation (TG) tested in vitro was consistent with resistance to high concentrations of rFVIIa but yielded good response to combinations of low doses of rFVIIa+FEIBA. In a desperate attempt to control the bleeding, concomitant therapy of 25 U/kg FEIBA and 40µg/kg rFVIIa was infused and resulted in arrest of bleeding within minutes. Over a span of about one year the patient has been successfully treated by this combination for more than 200 bleeding episodes in muscles and joints.
Condition | Intervention | Phase |
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Hemophilia A |
Drug: rFVIIa Drug: FEIBA- Activated Prothrombin Complexes |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Combination Therapy of Low Doses of rFVIIa and FEIBA for Severe Hemophilia A Patients With an Inhibitor to Factor VIII |
Ages Eligible for Study: | 16 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SHEBA-05-3768-UM-CTIL |
Study First Received: | January 17, 2006 |
Last Updated: | February 28, 2006 |
ClinicalTrials.gov Identifier: | NCT00284193 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Thrombin Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases |
Blood Coagulation Disorders Hemophilia A Hemostatic Disorders Factor VIII |
Blood Coagulation Disorders, Inherited Coagulants Coagulation Protein Disorders |
Therapeutic Uses Hematologic Agents Pharmacologic Actions |