drugset / Trial / NCT02246868

An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.

NCT02246868

Phase 3 Completed Bio Products Laboratory
Treatment

Summary

The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.

Timeline

Start
2001-09
Primary completion
2004-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Human Coagulation Factor VIII Protein / enzyme biologic

Indications