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
IRB#: 0508M73186
Trial Status: Open for enrollment
Phase: IV
Sponsor: Novartis Pharmaceuticals
Why is this study being done?
Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases. Over time the infection causes fibrosis and eventually cirrhosis of the new liver. The aim of this study is to see if the time to recurrence of liver fibrosis is longer with Neoral® than tacrolimus. The sponsor of this study, Novartis Pharmaceuticals, is the manufacturer of Neoral®.
Who is eligible to participate in the study?
Patients with end-stage liver disease due to hepatitis C cirrhosis receiving a first liver transplant from a deceased or living HCV+, HIV+ or HBV+ donor. Patients with any severe coexisting disease or suffering any unstable medical condition or co-infected with HBV or HIV; with co-existing alcoholic disease who have not been abstinent for at least 6 months; transplanted for liver cancer exceeding a pre-defined size.
Minimum age: 18 years
What is involved in the study?
You'll have 12 study visits during the 12 month study period and one follow up visit twelve months after the end of the study (i.e. at 24 months after your transplant). Some of these study visits will occur while you are still in the hospital after your transplant. You will have visits before your transplant, within 24 hours of your transplant, within 48 hours of your transplant, and at days 3, 5, 8, 15, 29 after your transplant as well as two months, three months, six months and 12 months after your transplant. You will have a follow-up visit 24 months after your transplant. The following procedures will be done at some or all visits: physical exam, blood draw for tests, liver biopsy, pregnancy test, vital signs taken, review of medications, dispensing of study medication.
How long will the study run?
You will be involved in the study for approximately 2 years.
Who can I contact to find out more about this trial?
Lila Schoelkoph, L.P.N. (612) 624-8475
What are the locations of this trial? University of Minnesota Medical Center, Fairview – Minneapolis, Minnesota
Novartis, East Hanover, NJ
Novartis Investigational Site, Germany
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