Rituximab (anti-CD20) for the Treatment of Hepatitis C Associated Cryoglobulinemic Vasculitis (HCV-CV)
Study Number
02-I-0096
Goal of Study
To determine the safety and efficacy of Rituximab in patients with HCV-CV
Study Regimen
Patients will be randomized to receive either Rituximab 375 mg/M2 on days 1, 8, 15 and 22, beginning at the time of enrollment or 6 months after enrollment. Patients in both groups will be maintained on stable doses of any immunosuppressive therapies that they were receiving at the time of enrollment. Response to Rituximab will be assessed by clinical and laboratory parameters. Patients will be followed for 12 months following the time of their last Rituximab infusion. Study drug will be provided.
Eligibility Criteria
- Age 18-75 years with documented HCV
- Objective evidence of vasculitis
- Failure or intolerance to treatment with IFN-alpha/ribavirin
- Must have personal physician responsible for HCV care
- Not pregnant or breast feeding
- Willing to use effective contraception during study and for 12 months following Rituximab treatment
- No new initiation or change in immunosuppressive therapy in past 4 weeks
- Not active infections other than HCV
- No prior treatment with Rituximab
- No history of liver transplant
- No co-infection with Hepatitis B (HBV) or HIV
- No underlying medical condition, that in the judgment of the investigator, would put the patient at serious infusion-related adverse events
For questions about participating in any of these clinical studies, contact:
Patient Recruitment and Public Liaison Office
Toll Free: 1-800-411-1222
TTY: 1-866-411-1010
Se habla español.
Office hours: 8 am to 8 pm, Eastern Time |
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