Clinical Trial: Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Patients With Hemophilia A
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Open-label, Non-comparative, Multicenter, Phase III for Evaluation of Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Previously Treated Patients With
Brief Summary: The purpose of this study is to study the evaluation of efficacy and safety of GreenGene (Recombinant Factor VIII).
Detailed Summary:
Sponsor: Green Cross Corporation
Current Primary Outcome:
- Physician's assessment of hemostatic effect for on-demand treatment [ Time Frame: 12 months ]Category: Exellent, Good, Moderate, None
- Hemostatic effect for major bleeding [ Time Frame: up to 1 year ]Category: Exellent, Good, Moderate, None
Original Primary Outcome: Same as current
Current Secondary Outcome:
- consumption amount of test drug [ Time Frame: up to 12 month or 100 exposure days ]
- Subject's self assessment of treatment [ Time Frame: 12 months ]Category: Exellent, Good, Moderate, None
- FVIII Recovery(%) [ Time Frame: every 3 months ]
- FVIII inhibitor incidence rate [ Time Frame: every 3 months ]
- The number of adverse events [ Time Frame: up to 1 year ]
- Surgery study: prohylactic effects [ Time Frame: up to 1 year ]Category: Exellent, Good, Moderate, None
Original Secondary Outcome: Same as current
Information By: Green Cross Corporation
Dates:
Date Received: March 22, 2012
Date Started: December 2004
Date Completion:
Last Updated: March 29, 2012
Last Verified: March 2012