NCT00989196

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Octapharma · Industry
• Sex: Male
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	Human-cl rhFVIII	50 IU/kg for PK dose
BIOLOGICAL	Kogenate FS	50 IU/kg for PK dose

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-10-01
• Completion: 2012-09-01
• First posted: 2009-10-02
• Last updated: 2019-10-08
• Results posted: 2014-01-17

Locations

9 sites across 3 countries: United States, Bulgaria, Germany