Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation.

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: Hepatitis C

Treatments: Drug: Pegylated interferon and ribavirin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00383864

PEG/RBV POST-TOH

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)