Pharmacokinetics of rFVIIIFc at Two Vial Strengths

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a randomized, open-label, crossover study during which each participant receives a single injection of rFVIIIFc from 2 different vial concentrations (PK assessment). After the PK assessment, participants are provided with rFVIIIFc for either prophylactic or episodic (on-demand) treatment for up to 6 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02083965
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 1
Start date	March 2014
Completion date	May 2015

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See also
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