Rituximab to Treat Hepatitis C-Associated Cryoglobulinemic Vasculitis
Hepatitis C, Vasculitis
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis, Vasculitis, Rituximab, Cryoglobulinemia, Hepatitis C, HcV-cV, Cryoglobulinemic Vasculitis
Eligibility Criteria
INCLUSION CRITERIA: Diagnosis of HCV-CV: must have all of the following HCV infection documented by serology and/or plasma HCV RNA. One or more organ system with objective evidence of active vasculitis such as: Palpable purpura; Glomerulonephritis (defined by the presence of glomerular hematuria and/or new or worsening proteinuria); Acute peripheral neuropathy. Detectable cryoglobulins and/or RF. Failure of treatment with IFN-alpha and ribavirin to control manifestations of HCV-CV OR intolerance to IFN-alpha/ribavirin regimen. Patients must have a personal physician responsible for the care of their HCV. Ages of 18 and 75 years Willingness to use effective contraception during and for 12 months following Rituximab treatment. Effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or hormonal contraception. EXCLUSION CRITERIA: Recent (within 4 weeks) initiation of or increase in immunosuppressive therapy. Active systemic infection (other than hepatitis C). Pregnancy or breast feeding. Prior treatment with Rituximab. Known allergy to murine proteins. Significant renal insufficiency (creatinine clearance less than 30 ml/min). Presence of life-threatening HCV-CV; defined as rapidly progressive glomerulonephritis (defined as a doubling of the serum creatinine over a 3 month period), CNS vasculitis, cardiac disease due to active vasculitis, or GI vasculitis (defined by ischemic bowel, perforation, or infarction). Significant hepatic insufficiency as manifested by Child-Pugh classification of B or C. History of variceal bleeding, encephalopathy. History of liver transplantation. Co-infection with either HBV or HIV. Any underlying medical condition that in the judgment of the investigator would put the patient at increased risk for serious infusion-related adverse events.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Arm 2
Other
Other
Immediate treatment
Delayed treatment
Patients receive treatment with four weekly infusions of rituximab 375mg/m2 immediately following randomization.
Patients treated with standard therapy (corticosteroids, plasma exchange, etc.). After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.