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

• Conditions: Chronic Hepatitis C in post-liver transplantation; MedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C; MedDRA version: 9.1Level: LLTClassification code 10024716Term: Liver transplantation

• Registration Number: EUCTR2009-010806-12-AT
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-26
• Last Update Posted: 27 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

• Male or female recipients of first liver transplant aged 18-70 years
• Liver transplant performed at least 6 months and up to 10 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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Serum creatinine >150 µmol/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, direct bilirubin >2 x ULN or 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)
• Breast feeding women.

Study & Design

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