drugset
drugset / Trial / NCT01863758

Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Patients With Severe Haemophilia A

NCT01863758 ↗

Phase 3 Completed 66 enrolled Octapharma
NaSingle-groupOpen-labelPrevention

Summary

To compare the number of breakthrough bleeds under tailored prophylaxis with Human cell line recombinant factor FVIII (Human-cl rhFVIII) with the historical bleeding rate from patients who received Human-cl rhFVIII as on demand treatment.

Timeline

Start
2013-08
Primary completion
2015-01
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Subject simoctocog alfa Protein / enzyme biologic 30 iu/kg Intravenous
Subject simoctocog alfa Protein / enzyme biologic 40 iu/kg Intravenous
Subject simoctocog alfa Protein / enzyme biologic 60 iu/kg Intravenous
Subject simoctocog alfa Protein / enzyme biologic 80 iu/kg Intravenous

Indications

severe hemophilia A