Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A
Active, not recruiting
Grifols Biologicals Inc.
Phase 4
2003-01-01
The purpose of this study is to determine the immunologic and overall safety associated with
long-term use of Alphanate in subjects diagnosed with severe hemophilia A (Factor VIII:C less
than 0.01 IU/ml), who have been previously treated with plasma-derived Factor VIII products
other than Alphanate and who have no history of developing either antibody inhibitors to
Factor VIII or nonspecific inhibitors of coagulation.
Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A
Active, not recruiting
Grifols Biologicals, LLC
Phase 4
2003-01-01
The purpose of this study is to determine the immunologic and overall safety associated with
long-term use of Alphanate in subjects diagnosed with severe hemophilia A (Factor VIII:C less
than 0.01 IU/ml), who have been previously treated with plasma-derived Factor VIII products
other than Alphanate and who have no history of developing either antibody inhibitors to
Factor VIII or nonspecific inhibitors of coagulation.
Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced)
Completed
Biotest Pharmaceuticals Corporation
N/A
2009-11-03
The purpose of this study is to evaluate whether a concentrate containing both FVIII and von
Willebrand Factor (VWF) given at a high dose will induce immune tolerance in subjects who
have already experienced and failed ITI with VWF-free FVIII concentrates. The treatment on
this study is expected to last up to 33 months.
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