Rituximab to Treat Severe Hemophilia A

Part of paid clinical trials in Orange, California.

Sponsor
Carelon Research
Study ID
NCT00331006
Phase
PHASE2
Status
Completed

Conditions

  • Hemophilia A

Eligibility Criteria

Sex
ALL
Age
18 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    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

Study Details

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.

Key Dates

Start date
Jun 30, 2006
Status verified
Jun 2013
Primary completion
Nov 30, 2010
Completion
Jan 31, 2012

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Rituximab administered at a dose of 375 mg/m2 by slow intravenous infusion once per week for 4 weeks

Primary Outcome Measure

Proportion of Subjects With Major Response, i.e. Inhibitor Level Falls to Less Than 5 BU/mL Between Weeks 6 to 22 and Remains Below 5 BU/mL at 5-7 Days Following Re-challenge With FVIII [ Time Frame: Measured within approximately 22 weeks ]

Locations (13)

FacilityCityStateZIPSite coordinators
Children's Hospital of Orange CountyOrangeCalifornia92868-
Children's Healthcare of AtlantaAtlantaGeorgia30322-
Rush University Medical CenterChicagoIllinois60612-
Tulane University Health Sciences CenterNew OrleansLouisiana70112-
Children's Hospital BostonBostonMassachusetts02115-
UNC at Chapel Hill HospitalChapel HillNorth Carolina27514-
University Hospital of ClevelandClevelandOhio44106-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Hemophilia Center of Western PennsylvaniaPittsburghPennsylvania15213-
University of Texas Southwestern Medical CenterDallasTexas75390-
Cook Children's Medical CenterFort WorthTexas76104-
Comprehensive Center for Bleeding DisordersMilwaukeeWisconsin53201-

Find similar trials in Orange, CA

By research site
Children's Hospital of Orange County· Orange, CAChildren's Healthcare of Atlanta· Atlanta, GARush University Medical Center· Chicago, ILTulane University Health Sciences Center· New Orleans, LAChildren's Hospital Boston· Boston, MAUNC at Chapel Hill Hospital· Chapel Hill, NC

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