Immunosuppression without calcineurin inhibitors and with the use of everolimus (Certican) in HCV-infected liver transplant patients - ChT-06-02

• Conditions: HCV cirrhosis; MedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis C

• Registration Number: EUCTR2007-006221-27-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Male and female patients aged between 18 and 75 years.
Recipients of an identical or compatible AB0 graft
Partients able to participate to the study with a written informed consent.
Patients with HCV-related cirrhosis.
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

Male and female patients aged between 18 and 75 years.
Recipients of an identical or compatible AB0 graft
Partients able to participate to the study with a written informed consent.
Patients with HCV-related cirrhosis.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.Comparison between study groups of the incidence and severity of histologically-proven rejection episodes.<br>2.Comparison between study groups of the incidence and severity of histologically-proven HCV recurrence.;Secondary Objective: 1.Comparison between study groups of patient and graft survival.<br>2.Comparison between study groups of the safety and tolerability of study drugs, with particolar reference to the cumulative incidence of infections, neurological complications, GI tract complications, diabetes, hyperlipemia, hypertension.<br>3.Comparison between study groups of renal function (serum creatinine) at 6, 12 and 24 post-LT months.<br>4. Comparison of the HCC recurrence rate.;Primary end point(s): The primary end-points of the study will be the following:<br>1.Comparison between study groups of the incidence and severity of histologically-proven rejection episodes.<br>2.Comparison between study groups of the incidence and severity of histologically-proven HCV recurrence.