NCT00938860

Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C

A Multi-center, Randomized, Open Label, Controlled Study to Compare the Sustained Virological Response During Treatment With Neoral or Tacrolimus in Maintenance Liver Transplant Recipients Treated With Pegylated Interferon and Ribavirin for Recurrent Hepatitis C

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the rates of Sustained Virological Response following anti-viral therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with recurrent Hepatitis C and treated with Neoral or tacrolimus.

Conditions

• Hepatitis C
• Liver Transplantation

Interventions

Type	Name	Description
DRUG	cyclosporin (Neoral)	Neoral capsules bid, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
DRUG	tacrolimus (Prograf)	Tacrolimus capsules bid, doses were adjusted as necessary to achieve and maintain recommended C0 target ranges.

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2009-07-14
• Last updated: 2015-05-22
• Results posted: 2014-05-26

Locations

45 sites across 13 countries: United States, Belgium, Brazil, Canada, Colombia, France, Germany, Italy, Russia, South Korea, Spain, Switzerland, United Kingdom