CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 39 enrolled
Drug / intervention
Cyclosporine +1 moredrug
Likely dose
Cyclosporine 4.0 mg/kgfrom 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/NCT00821587
NCT00821587Phase 4Completed
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Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

University of Florida·interventional·Posted Jan 13, 2009·Updated Jun 1, 2023

In Brief

A Phase 4 clinical trial evaluating Cyclosporine and Tacrolimus for Hepatitis C. Completed, enrolled 39 participants.

Detailed Summary

The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
Countries--
CollaboratorsNovartis Pharmaceuticals

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 13, 2009
Enrollment StartJun 1, 2004
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 17.5 years ago

Interventions

Cyclosporinedrug

Patients randomized to CsA had TAC discontinued and were treated with CsA at a dose of 2.0-4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150-200 ng/ml.

Tacrolimusdrug

Patients receiving TAC were treated with a dose of 0.08-0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10-15 ng/ml for the first month post-transplant followed by 5-10 ng/ml thereafter. Immunosuppression was typically tapered to monotherapy (TAC alone) within 4-6 months of transplantation.