Clinical trial NCT00260208: Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus
Official title: A Multicenter, Randomized, Open-label Study to Compare the Development of Liver Fibrosis at 12 Months After Transplantation for Hepatitis C Cirrhosis in Patients Receiving Either Cyclosporine Microemulsion or Tacrolimus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Liver Transplant
Hepatitis C
Keywords: Liver transplant, adults, hepatitis C, liver fibrosis, cyclosporine microemulsion, tacrolimus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver. The aim of this study was to see if the frequency of liver fibrosis was different with cyclosporine microemulsion than tacrolimus


Eligibility criteria: Inclusion criteria

* Reason for transplant is end-stage liver disease due to hepatitis C cirrhosis
* Patients receiving a first liver transplant from a deceased or living donor
* Patients in whom biopsies will be possible

Exclusion criteria

* Recipients of a liver from an hepatitis C virus positive (HCV+), human immunodeficiency virus positive (HIV+) or hepatitis B virus positive (HBV+) donor
* Patients with any severe coexisting disease or suffering any unstable medical condition or co-infected with HBV or HIV
* Patients with co-existing alcoholic disease who have not been abstinent for at least 6 months
* Transplanted for liver cancer exceeding a pre-defined size
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant
timeFrame: 1 year post-transplant
Secondary outcomes:
measure: Number of Participants With Combined Endpoint of Death or Graft Loss or Fibrosis Score (FS) ≥ 2
timeFrame: 1 year post-transplant
measure: Number of Participants With Fibrosing Cholestatic Hepatitis
timeFrame: 1 year post-transplantation
measure: Number of Participants With Death, Graft Loss, Death or Graft Loss, Graft Loss With Re-transplantation
timeFrame: 1 year post-transplant
measure: Number of Participants With Treated Acute Rejection, Biopsy Proven Acute Rejection (BPAR), and Sub-clinical Rejection
timeFrame: 1 year post-transplant
measure: Number of Participants With Combined Endpoint of Death or Graft Loss or Biopsy Proven Acute Rejection (BPAR)
timeFrame: 1 year post-transplant
measure: Number of Participants With Death or Re-transplantation Due to Recurrence of Hepatitis C Cirrhosis
timeFrame: 1 year post-transplant
measure: Number of Participants With Fibrosis Score 2 or Above [Ishak-Knodell Fibrosis Score (FS) ≥ 2] Within 1 Year Post-transplant (Intent to Treat Population)
timeFrame: 1 year post-transplant
measure: Mean Value of Liver Function Tests at 1 Year Post-transplantation
timeFrame: 1 year post-transplant
measure: Log-transformed Hepatitis C Virus Ribonucleic Acid (HCV RNA) Values up to 1 Year Post Transplant
timeFrame: Pre-transplant (Day 1), Day , Day 8, Day 29, Month 6 and 12 post- transplant
measure: Percentage of Participants With an Increase of at Least 1 Stage in Fibrosis
timeFrame: Between 1 and 2 years
measure: Mean Fibrosis Score
timeFrame: At 1and 2 years and its evolution over time
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Zurich
country: Switzerland
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: