Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus

Stopped early · Phase 4

Conditions studied: Liver Transplant, Hepatitis C

In brief

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

Key facts

Study ID

NCT00260208

Run by

Novartis Pharmaceuticals

People needed

361

Starts

2006-01-01

Last updated by the study team

2011-12-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — East Hanover, New Jersey, United States
• Novartis Investigational Site — Zurich, Switzerland

Full record on ClinicalTrials.gov

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