At a glance
ClinicalIndex Comparison Record- ✓Severe congenital hemophilia A
- ✓Documented historical inhibitor titer to factor VIII of at least 5 BU/mL
- ✓Inhibitor level ≥5 BU/mL measured 5-14 days after initial factor VIII exposure during screening
- ✕Known hypersensitivities or allergies to murine and/or humanized antibodies
- ✕HIV infected
- ✕Any immunodeficiency disorder
- ✕Hepatitis B infection (HBsAg positive, or HBsAg negative with HBcAb positive and HBV DNA positive)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Rituximab for the Treatment of Inhibitors in Congenital Hemophilia A (A TMH CTN Study)
In Brief
A Phase 2 clinical trial evaluating Rituximab for Hemophilia A. Completed, enrolled 23 participants across 13 sites.
Detailed 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.
Study Details
Timeline
Interventions
Rituximab by slow intravenous infusion; for participants greater than or equal to 10 kg, 375 mg per m\^2 BSA weekly for 4 weeks; for participants less than 10 kg, 12.5 mg/kg weekly for 4 weeks