drugset / Trial / NCT00989196

Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A

NCT00989196

Phase 2 Completed 22 enrolled Octapharma
RandomizedCrossoverOpen-labelTreatment

Summary

This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.

Timeline

Start
2010-05
Primary completion
2011-10
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator ADVATE Protein / enzyme biologic 50 iu/kg
Subject simoctocog alfa Protein / enzyme biologic 50 iu/kg

Indications