NCT00466219

Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (planned)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to assess whether patients with recurrent hepatitis C after liver transplantation will benefit from a treatment with ribavirin/PEG-IFN-alpha combined treatment for 48 weeks.

Detailed description

The aim of the study is to assess whether patients fulfilling the criteria as defined in section 3 will benefit from a treatment with ribavirin/PEG-a-IFN combined treatment. This study will be open to all patients with histologically documented hepatitis C recurring after LT, provided that all inclusion and exclusion criteria, as defined below, are met, and irrespectively of the pattern of response to a previous antiviral treatment (if any). The benefit will be assessed in terms of biochemical (normalization of serum transaminases levels), virological (disappearance of HCV RNA from serum) and histological (amelioration of the histological signs of hepatitis) response. The presence of a sustained virological response, as defined below in section 6, will also be studied in relation to the early kinetics of serum HCV RNA, in keeping with recent data obtained in chronic hepatitis C patients, which suggest that an early rapid decrease of HCV viremia is associated with a durable response.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Ribavirin
DRUG	Pegylated interferon alpha2a

Timeline

• Start date: 2002-05-01
• Completion: 2006-12-01
• First posted: 2007-04-27
• Last updated: 2007-04-27