Rituximab to Treat Severe Hemophilia A

Summary

Hemophilia A is a serious blood clotting disorder caused by a lack of factor VIII, a specialized protein needed for normal blood clotting to occur. Individuals with this disease may experience spontaneous bleeding, pain and swelling in their joints due to excess bleeding, and bruising. A common treatment for severe hemophilia A is to intravenously replace the deficient blood clotting factor; however, some individuals may develop antibodies to this replacement factor. This study will evaluate the effectiveness of rituximab at reducing the antibodies that develop in response to the replacement factor in individuals with severe hemophilia A.

Timeline

Start

2006-06

Primary completion

2010-11

Completion

2012-01

Outcome

Met primary endpoint

registry analysis (superiority or other test); Rituximab; p = 0.043; Proportion .1875; Exact Binomial; note: the a priori p-value was 0.05 for statistical significance NCT00331006 ↗

Drugs

Indications