Status:
COMPLETED
Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation.
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
Schering-Plough
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study was to evaluate the efficacy (and safety) of antiviral therapy in patients with chronic hepatitis C after liver transplantation. The only approved drugs for treatment of hepa...
Detailed Description
Hepatitis C recurrence after liver transplantation remains the main cause of graft loss after liver transplantation. Several strategies can be used to prevent or treat hepatitis C in the setting of li...
Eligibility Criteria
Inclusion
- Chronic hepatitis C defined by liver biopsy and presence of HCV-RNA
- More than 6 months from liver transplantation
- Written inform consent
Exclusion
- Severe hepatitis C recurrence (F3-F4 fibrosis stage, cholestatic hepatitis)
- Double liver-kidney transplantation
- Leucopenia (2000) or thrombocytopenia (40.000)
- Anemia (Hemoglobin lower than 10 g/dL)
- Renal failure (creatinine \> 2 mg/dL)
- Autoimmune disease
- All contraindications for interferon and ribavirin therapy
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00383864
Start Date
July 1 2001
End Date
March 1 2006
Last Update
October 6 2006
Active Locations (1)
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1
Liver Unit, Hospital Clinic
Barcelona, Spain, 08036