NCT00586521

BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 30 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematologic Disease
• Hemophilia A

Interventions

Type	Name	Description
DRUG	Kogenate (BAY14-2222)	One group two treatment schedules, first on-demand then switch to prophylaxis

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-01-04
• Last updated: 2014-11-03
• Results posted: 2009-11-19

Locations

11 sites across 5 countries: United States, France, Italy, Spain, United Kingdom