Status:
TERMINATED
Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Liver Transplant
Hepatitis C
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
361 Patients enrolled
Trial Details
Trial ID
NCT00260208
Start Date
January 1 2006
Last Update
December 6 2011
Active Locations (2)
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1
Novartis Investigative Site
East Hanover, New Jersey, United States
2
Novartis Investigational Site
Zurich, Switzerland, 8091