CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
Mycophenolate to sirolimus switchdrug
Likely dose
Mycophenolate to sirolimus switch 1 mgfrom 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/NCT01134952
NCT01134952Phase 4Completed

A Prospective Cross-over Study Comparing the Effect of Sirolimus Versus Mycophenolate on Viral Load in Liver Transplant Recipients With Recurrent Chronic HCV Infection

London Health Sciences Centre·interventional·Posted Jun 2, 2010·Updated Feb 26, 2015

In Brief

A Phase 4 clinical trial evaluating Mycophenolate to sirolimus switch for Hepatitis C. Completed, enrolled 11 participants across 1 site.

Detailed Summary

Different immunosuppressive drugs used in transplantation may reduce the body's defences against infection differently. It is known that patients with Hepatitis C virus, known as HCV, who switched from azathioprine to mycophenolate mofetil experienced an increase in viral load. Despite this, mycophenolate mofetil is used because it prevents rejection more reliably than azathioprine. Sirolimus is an another immunosuppressive agent that reliably prevents rejection and may have antiviral activity. This study is designed to see if the viral load of HCV and other viruses is reduced by switching from mycophenolate to sirolimus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2, 2010
Enrollment StartJun 1, 2010
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 16.1 years ago

Interventions

Mycophenolate to sirolimus switchdrug

Sirolimus given for 3 months instead of mycophenolate at a starting dose equivalent of 1 mg sirolimus equal to 1000 mg of mycophenolate.