Randomized Study on the Efficacy and Safety of Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 55
- Locations
- 2
- Primary Endpoint
- Histological improvement (decrease in at least one fibrosis stage in follow-up liver biop
Study Overview
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 hepatitis C are pegylated interferon and ribavirin.
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 liver transplantation. There are no controlled studies evaluating the efficacy and safety of antiviral treatment (using pegylated interferon and ribavirin) in liver transplant recipients. The main endpoint of this study was: 1) histological outcomes (effect of antiviral treatment on disease progression, i.e. liver fibrosis). The secondary endpoint were 1) Sustained virological response (persistent HCV-RNA clearance) and 2) Safety of pegylated interferon and ribavirin
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chronic hepatitis C defined by liver biopsy and presence of HCV-RNA
- •More than 6 months from liver transplantation
- •Written inform consent
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Histological improvement (decrease in at least one fibrosis stage in follow-up liver biop
Secondary Outcomes
- Sustained virological response (persistent HCV-RNA negativation)
- Safety of antiviral therapy