Clinical Trial: Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized, Controlled, Parallel, Prospective Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subj
Brief Summary: To evaluate the effect of secondary prophylaxis as compared to episodic treatment on bleeding frequency (number of bleeds per year) and on joint damage.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: Bleeding Frequency (Number of Total Bleeds) [ Time Frame: After the last enrolled patient has been in the study for 1 year. At the cut-off, the median follow-up duration was 616 days (minimum was 111 days and maximum was 1109 days) ]
Original Primary Outcome: Bleeding frequency. [ Time Frame: Three years ]
Current Secondary Outcome:
- Change From Baseline to 3 Years in the MRI (Magnetic Resonance Imaging) Scale. [ Time Frame: Baseline and 3 years ]The Extended MRI Scale total score has a range between 0 (normal unaffected joint) to 45 (maximal joint damage) points. It is composed of 2 domains, the soft tissue domain with a maximum of 9 points and the osteochondral domain with a maximum of 36 points. A single score for each subject was to be calculated from the sum of both domains and the average over all joints for the Extended MRI endpoint. Higher MRI score denotes greater joint structure damage thus a positive change from baseline means worsening.
- Change From Baseline to 3 Years in the Colorado Adult Joint Assessment Scale [ Time Frame: Baseline and 3 years ]The total joint score is derived for each of six joints: left and right sides for knees (score: 0-25), ankles (score: 0-25), and elbows (score: 0-21). Higher CAJAS (Colorado Adult Joint Assessment Scale) score denotes greater joint structure damage thus a positive change from baseline means worsening. CAJAS total score is the sum of all 6 joints, ranging from 0 (best possible outcome) to 142 (worst possible outcome).
Original Secondary Outcome: Anatomical Joint damage by MRI (in the 6 index joints). [ Time Frame: Three years ]
Information By: Bayer
Dates:
Date Received: February 4, 2008
Date Started: March 2008
Date Completion:
Last Updated: November 5, 2014
Last Verified: November 2014
