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Combination Therapy of Low Doses of rFVIIa and FEIBA for Severe Hemophilia A Patients With an Inhibitor to Factor VIII

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00284193
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : July 27, 2012
Information provided by (Responsible Party):
Prof. Uriel Martinowitz, Sheba Medical Center

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 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 or disease Intervention/treatment Phase
Hemophilia A Drug: rFVIIa-FEIBA therapy for hemophilia A inhibitors Drug: FEIBA- Activated Prothrombin Complexes Phase 4

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.

The combination yielding sufficient hemostasis was depicted for patients' therapy of future bleeding episodes.

Following actual therapy hemostasis and safety parameters were monitored.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Therapy of Low Doses of rFVIIa and FEIBA for Severe Hemophilia A Patients With an Inhibitor to Factor VIII
Study Start Date : January 2005
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: feiba-VIIa, hemophilia A-inhibitor therapy
Drug: rFVIIa-FEIBA therapy for hemophilia A inhibitors
DOses tailored per ex vivo spiking thrombin generation
Other Names:
  • APCC

Drug: FEIBA- Activated Prothrombin Complexes

Primary Outcome Measures :
  1. Hemostasis achieved post therapy [ Time Frame: 6-24 hours ]
    Following acute bleeding therapy hemostasis was defined as good, partial or non-satisfactory

  2. Safety [ Time Frame: 0-24 HOURS ]
    Following therapy presence of any adverse events, especially thromboembolic complications was assessed

Secondary Outcome Measures :
  1. Time to Hemostasis [ Time Frame: 0-24 HOURS ]
    Following therapy patients documented time to "GOOD" response

Other Outcome Measures:
  1. Coagulation Studies [ Time Frame: 0-24 HOURS ]
    cbc fibrinogen and D-dimer were assessed pre and post therapy, thrombin generation was assayed when possible after 1-2 hours

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hemophilia patients with inhibitors
  • Patients signing informed consent

Exclusion Criteria:

  • Patients under 16 or above 65
  • Patients with allergic reaction or adverse events in previous use the concentrates
  • Patients with high risk of thrombosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00284193

Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Uri Martinowitz, MD Sheba Medical Center
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Responsible Party: Prof. Uriel Martinowitz, Prof. Uri Martinowitz, Sheba Medical Center Identifier: NCT00284193    
Other Study ID Numbers: SHEBA-05-3768-UM-CTIL
First Posted: January 31, 2006    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: July 2012
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Anti-inhibitor coagulant complex
Factor VIII