NCT01341912

Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs)

Clinical Study to Investigate the Long-Term Efficacy, Safety and Immunogenicity of Human-cl rhFVIII in Previously Treated Patients With Severe Haemophilia A - Extension Study to GENA-01

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Octapharma · Industry
• Sex: Male
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to study the long-term efficacy, safety and tolerability of Human-cl rhFVIII in previously treated patients with severe hemophilia A.

Conditions

• Severe Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	Human-cl rhFVIII	Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery.

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-04-26
• Last updated: 2020-03-17
• Results posted: 2014-02-03

Locations

2 sites across 2 countries: United States, Bulgaria