Development of liver fibrosis after transplantation for hepatitis C cirrhosis. MedDRA version: M15 Level: LLT Classification code 10016648
Conditions
Interventions
Product Name: Neoral 10mg Soft gelatin capusles
Product Code: OLO400
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ciclosporin
CAS Number: 59865-13-3
Current Sponsor code: OLO400
Other descr
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Reason for transplant is end-stage liver disease due to hepatitis C cirrhosis •Male or female aged 18 to 75 years •Patients receiving a first liver transplant from deceased or living donor •Patients willing and capable of giving written informed consent for study participation • Patients in whom allograft biopsies will be possible • Patients in whom the immunosuppressive regimen described in this protocol will be initiated and maintained for the entire study period 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: •Multi-organ transplant recipients •Transplanted with an organ from a non-heart beating donor •Patients receiving an ABO incompatible liver •Expected to receive induction therapy with ATG/ALG or OKT3 •HBV/HIV co-infected patients •Recipients of an organ from an HCV+ or HIV+ or HBV+ donor • Patients with a serum creatinine =2.0 mg/dL (=177 µmol/L) prior to transplantation or if renal dialysis is necessary prior to transplantation • Patients with severe coexisting disease or presenting with any unstable medical condition which could affect the study objectives • Patients who are not eligible to receive the recommended calcineurin inhibitor starting dose within 24 hours of transplantation • Patients with a co-existing alcoholic disease who have not been abstinent for at least 6 month immediately prior to transplantation and are not expected to be able to remain abstinent after transplantation •Patients who are unlikely to comply with the study requirements or unable to give informed consent •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer or if such therapy is to be instituted post-transplantation •History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures •Patients transplanted for hepatocellular carcinoma exceeding the Milan criteria, defined as presence of a tumour 5 cm or less in diameter in patients with single hepatocellular carcinoma and no more than 3 tumor nodules, each 3 cm or less in diameter in patients with multiple tumors •History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml) •Women of child-bearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the rate of fibrosis stage 2 or above (Ishak-Knodell FS > = 2 ) at 1 year post-transplantation is lower in hepatitis C positive patients receiving Neoral versus tacrolimus.;Secondary Objective: •To compare the rate of the combined endpoint of death or graft loss or FS=2 by 1 year post-transplant and at the 2- and 3-year follow-up visits • To compare the occurrence rate of FS=2 at the 2- and 3-year follow-up visits •To compare the occurrence rate of fibrosis stage 2 or above at the 2 year and 3 year follow-up visits •To compare the mean fibrosis score at 1, 2 and 3 years and its evolution over time in each arm •To compare the percentage of patients with an increase of at least 1 stage in fibrosis between 1 and 2 years, and between 1 and 3 years. •To compare the incidence of fibrosing cholestatic hepatitis by 1 year •To compare viral kinetic post transplant in both arms up to 1 year post-transplantation and at the 2 and 3 year follow-up visits • To compare the time to first signs of histological recurrence of hepatitis C (clinically suspected recurrence confirmed by biopsy) ;Primary end point(s): Incidence of rate of fibrosis stage 2 or above (Ishak-Knodell FS >=2) at one year post-transplantation in hepatitis C positiv patients. | — |
Countries
Belgium, Czech Republic, Germany, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed