Clinical Trial: BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective Controlled Study on the Effect on Bleeding Events and Joint Function in Young Adults With Severe Hemophilia A After a 6 Month Prophylaxis Treatment Compared to on Demand Treatment

Brief Summary:

The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design.

In addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.


Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: Number of Joint Bleeds [ Time Frame: Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment) ]

Number of joint bleeds during Months 8-13 compared to number of joint bleeds during Months 1-6


Original Primary Outcome: Evaluate the effect of prophylactic treatment on the number of joint bleeds in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design. [ Time Frame: Feb 2006 to March 2008 ]

Current Secondary Outcome:

  • Number of All Bleeds [ Time Frame: Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment) ]
    Mean number of all bleeds during Months 8-13 (prophylactic) compared to mean number of all bleeds during Months 1-6 (on-demand)
  • Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Score [ Time Frame: Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment) ]
    Total score with a range of 0-100, evaluating ankle, knee and elbow, 0 indicates normal function, higher values indicate joint damage
  • Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnaire [ Time Frame: Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment) ]
    Total transformed score with a range of 0-100, higher values indicate better outcome. 41 items in 6 domains: physical functioning; role functioning; worry; consequences; positive affect; treatment concern.


Original Secondary Outcome:

  • Evaluate the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment. [ Time Frame: Feb 2006 to March 2008 ]
  • Health-economic data will also be assessed. [ Time Frame: Feb 2006 to March 2008 ]


Information By: Bayer

Dates:
Date Received: December 21, 2007
Date Started: February 2006
Date Completion:
Last Updated: October 27, 2014
Last Verified: October 2014