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

Phase 1

• Conditions: Chronic Hepatitis C in post-liver transplantation; MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10024716Term: Liver transplantationSystem Organ Class: 100000004865

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-27
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 92

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.
• 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

Exclusion Criteria

• 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