drugset / Trial / NCT02083965

Pharmacokinetics of rFVIIIFc at Two Vial Strengths

NCT02083965

Phase 1 Completed 19 enrolled Bioverativ Therapeutics Inc.
RandomizedCrossoverOpen-labelTreatment

Summary

The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK assessment for up to 6 months for a continued treatment period.

Timeline

Start
2014-03
Primary completion
2014-10
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Efmoroctocog Alfa Protein / enzyme biologic 20 iu/kg Intravenous
Subject Efmoroctocog Alfa Protein / enzyme biologic 50 iu/kg Intravenous
Subject Efmoroctocog Alfa Protein / enzyme biologic 65 iu/kg Intravenous

Indications