BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)

Completed · Phase 4

Conditions studied: Hematologic Disease, Hemophilia A

In brief

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.

Key facts

Study ID

NCT00586521

Run by

Bayer

People needed

20

Starts

2006-02-01

Expected to finish

2008-03-01

Last updated by the study team

2014-11-03

Who can join

Age: 30 and older, up to 45. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Severe hemophilia A (< 1% FVIII)
• 30-45 years of age
• Previously treated subject (> 100 Exposure days to any FVIII)
• On-demand therapy with any FVIII

You may not qualify if…

• No history of inhibitor
• No planned elective orthopedic surgery during the study duration (13 months)
• No severe concomitant disease
• No history of anaphylactic or other severe reaction to previous FVIII treatment

Where it is running

• Study site — Aurora, Colorado, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Strasbourg, France
• Study site — Florence, Italy
• Study site — Pavia, Italy
• Study site — Roma, Italy
• Study site — Madrid, Madrid, Spain
• Study site — Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
• Study site — Cardiff, South Glamorgan, United Kingdom
• Study site — Sheffield, South Yorkshire, United Kingdom

Full record on ClinicalTrials.gov

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