Role of immunosuppression with steroids in the outcome of fibrosis due to recurrent hepatitis C virus (HCV) infection after liver transplantation - Epaster 2

• Conditions: fibrosis due to recurrent hepatitis C virus (HCV) infection after liver transplantation; MedDRA version: 9.1Level: LLTClassification code 10016648Term: Fibrosis liver

• Registration Number: EUCTR2008-002295-10-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-12
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

 Chronic hepatitis C carriers undergoing liver transplantation, also if concomitant hepatocellular carcinoma (HCC)  Age equal to or above 18 anni  Liver transplantation performed using cadaveric full-size graft  Negative serological status with regard to hepatitis B (HBV) infection with the exception of HBsAg / HBV-DNA negative but anti-HBs and/or anti-HBc positive recipients  Written approval of the informed consent according to ICH-GCP
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

 Anti-HCV positive donor  HBsAg positive donor  AB0 incompatibile donor  Re-transplants  Alcoholic liver disease  HIV-positive recipients  Fulminant hepatic failure  Lack of compliance to the procedures scheduled in the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified