Status:
COMPLETED
Rituximab to Treat Severe Hemophilia A
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Genentech, Inc.
Conditions:
Hemophilia A
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 spontan...
Detailed Description
Hemophilia A is a hereditary blood clotting disorder. It is caused by a deficiency or abnormality of the blood clotting protein factor VIII. Individuals with hemophilia A are unable to form blood clot...
Eligibility Criteria
Inclusion
- Severe congenital hemophilia A
- Documented historical inhibitor titer to factor VIII of at least 5 BU/mL
- Inhibitor level greater than or equal to 5 BU/mL 5 to 14 days after initial factor VIII exposure during screening
Exclusion
- Known hypersensitivities or allergies to murine and/or humanized antibodies
- Currently participating in investigational hemophilia studies
- HIV infected
- Any immunodeficiency disorder
- Liver disease and serum ALT or AST is greater than three times the upper limit of normal, albumin is less than 2.5g/dl, and/or INR is greater than 1.7
- Received interferon or other immunomodulatory drugs, such as steroids or cytotoxic therapy in the 30 days prior to study entry
- History of cardiac arrhythmias, any active febrile illness, kidney insufficiency, or pulmonary infiltrates
- Has previously received rituximab treatment
- Currently undergoing immune tolerance therapy
- Evidence of Hepatitis B (HBV) infection, defined as one of the following:
- HBsAg positive
- HBsAg negative, HBsAb negative, HBcAb positive, and HBV DNA positive
- Participants with a high responding inhibitor (at least 5 BU/mL) first detected fewer than 12 months prior to study entry, unless the participant has failed immune tolerance therapy, defined as one of the following:
- Failure to fulfill the criteria for full or partial success within 33 months, as defined by a factor VIII recovery greater than or equal to 66% of expected and half-life greater than or equal to 6 hours measured after a 72-hour treatment-free washout period
- Failure to achieve greater than 20% reduction in inhibitor titer during each interim non-overlapping 6-month period of ITT in the absence of documented infection, with 9 months as the minimum treatment period and 33 months as the maximum possible duration of unsuccessful ITT
- Withdrawal from ITT for any other reason
- Routinely receive factor VIII concentrate for the treatment of both major and minor bleeding events
- Has received factor VIII concentrate in the 7 days prior to study entry
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00331006
Start Date
June 1 2006
End Date
January 1 2012
Last Update
June 11 2013
Active Locations (13)
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1
Children's Hospital of Orange County
Orange, California, United States, 92868
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
4
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112