NCT00260208

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 361 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Liver Transplant
• Hepatitis C

Interventions

Type	Name	Description
DRUG	Cyclosporine A	Initial dose of 10-15mg/kg/day either orally, via a nasogastric (NG) tube or intravenously (i.v.) within the first 24 hours post-transplantation.
DRUG	Tacrolimus	Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses either orally or via a nasogastric (NG) tube or intravenously (i.v).

Timeline

• Start date: 2006-01-01
• Primary completion: 2010-09-01
• First posted: 2005-12-01
• Last updated: 2011-12-06
• Results posted: 2011-10-26

Locations

2 sites across 2 countries: United States, Switzerland