Research Directory Details | National Medical Research Register

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

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