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 transplantationMedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.1Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 100000004865Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2009-010806-12-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 92
• 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.
• Immunosuppressive regimen based on tacrolimus (twice- or once-daily formulations) for at least 6 months prior to randomization
• Diagnosis of HCV genotype 1 or 4 infection 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
• Serum creatinine >150 µmol/L (1.7 mg/dL) or eGFR < 50 mL/min (Cockcroft-Gault formula)
• Multi-organ transplant recipients
• Recent episode of steroid treated acute rejection (AR) within 3 months prior to randomization, or >1 steroid-treated 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, or 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)
• Concomitant disease such as uncontrolled severe hypertension, heart failure, significant coronary heart disease, uncontrolled diabetes, obstructive pulmonary disease that could limit the participation until the completion of the trial
• Patients with conditions that could potentially worsen with antiviral treatment, such as severe psychiatric disease, auto-immune diseases and others
• Patients with clinically significant systemic infection
• Use of other investigational drugs at the time of enrollment or within 30 days or 5 halflives of enrollment, whichever is longer
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or to antiviral therapy
• Women of child bearing potential, defined as all women physiologically capable of
becoming pregnant including women whose career, lifestyle, or sexual orientation
precludes intercourse with a male partner, and women whose partners have been sterilizedby vasectomy or other means, unless they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. Periodic abstinence (e.g., calendar, ovulation, symptom thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• A negative pregnancy test at Visit 1 must be obtained immediately prior to initiation of therapy.
• Fertile males, defined as all males physiologically capable of conceiving offspring unless the patient and his partner agree to comply with acceptable contraception as described above.
• Breast feeding women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method