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