drugset / Trial / NCT00323856

Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A

NCT00323856 ↗

Phase 4 Completed 51 enrolled Grifols Biologicals, LLC
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2003-04-08
Primary completion
2018-12-11
Completion
2018-12-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Alphanate SD/HT Protein / enzyme biologic — —

Indications