CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 19 enrolled
Drug / intervention
mycophenolate mofetil +1 moredrug
Likely dose
Mycophenolate mofetil with 50% reduction in baseline calcineurin inhibitor dose, or mycophenolate mofetil monotherapyAI-extracted
Key inclusion· 3
  • ✓Age ≥18 years
  • ✓Orthotopic liver transplant performed >1 year prior to enrollment
  • ✓Currently using calcineurin inhibitor for rejection prevention
Key exclusion· 13
  • ✕Liver disease secondary to autoimmune causes (autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cirrhosis)
  • ✕More than one prior episode of rejection
  • ✕Rejection within the past 6 months
  • ✕Any corticosteroid-resistant rejection

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

Search/NCT00206076
NCT00206076Phase 4Completed
CompareCT.gov

CellCept (Mycophenolate Mofetil, MMF) Maintenance Immunosuppression in Liver Transplant Recipients With Long-term Follow-up Post-transplantation for Non-Autoimmune Liver Disease - A Prospective, Randomized, Multicenter Trial.

Albert Einstein Healthcare Network·interventional·Posted Sep 21, 2005·Updated Aug 2, 2013

In Brief

A Phase 4 clinical trial evaluating mycophenolate mofetil for Liver Disease. Completed, enrolled 19 participants across 3 sites.

Detailed Summary

The purpose of the study is to assess the safety and efficacy of mycophenolate mofetil alone, or with reduced dose cyclosporine (CsA) or tacrolimus, for immunosuppression long-term after liver transplantation, in an attempt to reduce the potential side effects from using cyclosporine or tacrolimus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Disease
CountriesUnited States
CollaboratorsHoffmann-La Roche

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartAug 1, 2006
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.8 years ago

Interventions

mycophenolate mofetildrug

mycophenolate mofetil and half their baseline dose of calcineurin inhibitor

mycophenolate mofetildrug

mycophenolate mofetil monotherapy