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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006221-27-IT
Enrollment
Unknown
Registered
2008-06-03
Start date
2008-04-01
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV cirrhosis MedDRA version: 9.1 Level: LLT Classification code 10019744 Term: Hepatitis C

Interventions

Trade Name: CERTICAN*60CPR 0,75MG Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .75- Trade Name: PROG

Sponsors

AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: 1. Comparison between study groups of the incidence and severity of histologically-proven rejection episodes. 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. 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. 3. Comparison between study groups of renal function (serum creatinine) at 6, 12 and 24 post-LT months. 4. Comparison of the HCC recurrence rate.;Primary end point(s): The primary end-points of the study will be the following: 1. Comparison between study groups of the incidence and severity of histologically-proven rejection episodes. 2. Comparison between study groups of the incidence and severity of histologically-proven HCV recurrence.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026