NCT00383864

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

Randomized Study on the Efficacy and Safety of Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (planned)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Pegylated interferon and ribavirin

Timeline

• Start date: 2001-07-01
• Completion: 2006-03-01
• First posted: 2006-10-04
• Last updated: 2006-10-06

Locations

1 site across 1 country: Spain