A multi-center, randomized, open label, controlled study to compare the Sustained Virological Response during treatment with Neoral or tacrolimus in maintenance liver transplant recipients treated with pegylated interferon and ribavirin for recurrent Hepatitis C - ND

Phase 1

• Conditions: Chronic Hepatitis C in post-liver transplantation; MedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

• Registration Number: EUCTR2009-010806-12-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-03
• Study Completion: 2013-05-01
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Male or female recipients of first liver transplant aged 18-65 years Liver transplant performed at least 6 months and up to 5 years prior randomization and due to HCV cirrhosis, with or without pre-transplant hepatocellular carcinoma (HCC) within Milan or UCSF criteria Immunosuppressive regimen based on tacrolimus b.i.d for at least 6 months prior to randomization Diagnosis of HCV genotype 1 or 4 infection prior to transplantation and confirmed at screening Indication of treatment with Peg-IFN and ribavirin due to histological evidence of chronic HCV infection defined as a fibrosis stage equal or greater than 1 using the Ishak-Knodell scoring system (IK ≥1) in a liver biopsy performed at screening or up to 4 months prior to randomization Patients must give written informed consent before any study assessment is performed.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Serum creatinine >150 &#956;mol/L (1.6 mg/dL) or eGFR < 50 mL/min (4-variable Modification of Diet in Renal Disease [MDRD formula]) Multi-organ transplant recipients Recent episode of acute rejection (AR) within 3 months prior to randomization, or >1 episode of AR in the last 6 months, or any number of steroid-resistant AR episodes in the last 6 months including evidence of chronic rejection or ductopenia Evidence of conditions that could cause graft dysfunction other than HCV infection Patients with signs of decompensated liver disease, defined as presence of ascites, variceal bleeding, encephalopathy or deteriorated hepatic synthetic function (albumin <3.5g/dL, total bilirubin >1.5mg/dL, INR >1.5) Co-infection with HIV or Hepatitis B (defined as HBsAg-positive) Use of mTOR inhibitors (everolimus or sirolimus) in the 6 months prior to screening Antiviral treatment for HCV administered at any time after liver transplantation Patients on daily doses of corticosteroids higher than 5 mg/day Patients with fibrosing cholestatic hepatitis Patients with current diagnosis of malignancies, including lymphoproliferative disorders Patients with platelet count <70,000/mm3 or neutrophiles <1,500/mm3 History of HCC outside Milan criteria based on radiology or UCSF criteria based on analysis of the explant History of malignancy of any organ system within the past 5 years (other than non-metastatic basal or squamous cell carcinoma of the skin)

Study & Design

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