CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 92 enrolled
Drug / intervention
cyclosporin (Neoral) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00938860
NCT00938860Phase 4Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Jul 14, 2009·Updated May 22, 2015

In Brief

A Phase 4 clinical trial evaluating cyclosporin (Neoral) and tacrolimus (Prograf) for Hepatitis C and Liver Transplantation. Completed, enrolled 92 participants across 45 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Liver Transplantation
CountriesBelgium, Brazil, Canada, Colombia, France, Germany, Italy, Russia, South Korea, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2009
Enrollment StartSep 1, 2009
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 17.0 years ago

Interventions

cyclosporin (Neoral)drug

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

tacrolimus (Prograf)drug

Tacrolimus capsules bid, doses were adjusted as necessary to achieve and maintain recommended C0 target ranges.