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

Phase 4

Completed

• Conditions: Hepatitis C

• Registration Number: NCT00383864
• Lead Sponsor: Hospital Clinic of Barcelona

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 Timeline

• Study Start: 2001-07
• Study Completion: 2006-03
• Status Verified: 2006-10
• Study First Submitted: 2006-10-02
• Study First Submitted QC: 2006-10-02
• Study First Posted: 2006-10-04
• Last Update Submitted: 2006-10-05
• Last Update Posted: 2006-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Histological improvement (decrease in at least one fibrosis stage in follow-up liver biop

Secondary Outcome Measures

Name	Time	Method
Sustained virological response (persistent HCV-RNA negativation)
Safety of antiviral therapy

Trial Locations

Locations (1)

Liver Unit, Hospital Clinic; 🇪🇸 Barcelona, Spain