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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002295-10-IT

Enrollment

100

Registered

2008-06-12

Start date

2008-10-14

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

fibrosis due to recurrent hepatitis C virus (HCV) infection after liver transplantation MedDRA version: 9.1 Level: LLT Classification code 10016648 Term: Fibrosis liver

Interventions

Trade Name: DELTACORTENE*10CPR 25MG Pharmaceutical Form: Tablet INN or Proposed INN: Prednisone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: PRO

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess its histological severity of the fibrosis induced by hepatitis C recurrence after liver transplantation and to correlate it with two different schedules of steroid treatment employed as part of the immunosuppressive therapy based on tacrolimus. Patients will be randomized into two different groups: group A will receive steroids according to a rapid tapering schedule and have them withdrawn at the end of the third postoperative month, while group B will receive steroids according to a slow tapering schedule and have them withdrawn at the end of the 24th postoperative month;Secondary Objective: To assess patient and graft survival, clinical severity of recurrent hepatitis C, HCV viral kinetics and incidence and severity of side effects and to correlate them with two different schedules of steroid treatment employed as part of the immunosuppressive therapy.;Primary end point(s): Fibrosis assessed in the liver biopsy specimens taken 12 and 24 months after transplantation and scored according to the Scheuer system	—

Measure

Time frame

Main Objective: To assess its histological severity of the fibrosis induced by hepatitis C recurrence after liver transplantation and to correlate it with two different schedules of steroid treatment employed as part of the immunosuppressive therapy based on tacrolimus. Patients will be randomized into two different groups: group A will receive steroids according to a rapid tapering schedule and have them withdrawn at the end of the third postoperative month, while group B will receive steroids according to a slow tapering schedule and have them withdrawn at the end of the 24th postoperative month;Secondary Objective: To assess patient and graft survival, clinical severity of recurrent hepatitis C, HCV viral kinetics and incidence and severity of side effects and to correlate them with two different schedules of steroid treatment employed as part of the immunosuppressive therapy.;Primary end point(s): Fibrosis assessed in the liver biopsy specimens taken 12 and 24 months after transplantation and scored according to the Scheuer system

—

Countries

Italy

Outcome results

None listed

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