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A study of immunologic safety for Alphanate® in previously treated patients diagnosed with severe Hemophilia A

A study of immunologic safety for Alphanate® in previously treated patients diagnosed with severe Hemophilia A

Alphanate Safety Study

General Information
Research Type
Observational
Description
This is a multi-center, open label, single group trial designed to evaluate the immunologic and general safety of long term use of Alphanate in patients diagnosed with severe Hemophilia A who have been previously treated with Factor VIII concentrates. Patient participation in this study will last for at least two years or a minimum of 50 exposure days, during which time the patient will be treated exclusively with Alphanate for prophylaxis, bleeding episodes, and surgery. Medical assesment would at a specified interval during the course of the study.
Study Information
RMK Priority Area
Research Level
Research Keyword
alphanate, hemophilia, antihemophilic factor, AHF, factor VIII
Inclusion & Exclusion Criteria
Inclusion Criteria
Males diagnosed with severe hemophilia A who have been previously treated with factor Vll concentrates, cryoprecipitate, or whole blood for a total of 150 cumulative exposure days: at least six years and not more than 65 years of age, who have no history of exposure to Alphanate and who have never been diagnosed with antibody inhibitors to factor Vll or to nonspecific inhibitors of coagulation.
Exclusion Criteria
Males diagnosed with severe hemophilia A who have been previously treated with factor Vll concentrates, cryoprecipitate, or whole blood for a total of 150 cumulative exposure days: at least six years and not more than 65 years of age, who have no history of exposure to Alphanate and who have never been diagnosed with antibody inhibitors to factor Vll or to nonspecific inhibitors of coagulation.
Study Timeline
Expected / Actual Date Study Starts - First Enrolment of subject / Collecting data
Mar, 26 2002
Expected / Actual Date Study Completed
Expected / Actual Duration of Study Enrollment / Data Collection