CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Enteric-coated Mycophenolate Sodiumdrug
Likely dose
Enteric-coated Mycophenolate Sodium 1440mgfrom 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/NCT01467011
NCT01467011N/ACompleted
CompareCT.gov

An Open-label Study of the Pharmacokinetics of Mycophenolic Acid as Myfortic (Enteric-coated Mycophenolate Sodium) When Used in Combination With Prograf (Tacrolimus) and Corticosteroids in Patients Undergoing de Novo Liver Transplantation

R. Mark Ghobrial, MD·observational·Posted Nov 8, 2011·Updated May 16, 2018

In Brief

An observational study evaluating Enteric-coated Mycophenolate Sodium for End Stage Liver Disease. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The purpose of this study is to gather information regarding the use of Myfortic, Prograf, and corticosteroids in new liver transplant recipients. These three medicines help to prevent the body from rejecting the transplanted liver. The information the investigators are obtaining is data relating to the process of Myfortic absorption by the body, its distribution in the body, the breakdown of Myfortic in the body, and its elimination from the body. This absorption, distribution, breakdown, and elimination is called pharmacokinetics.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Liver Disease
CountriesUnited States
CollaboratorsNovartis

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 8, 2011
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 14.7 years ago

Interventions

Enteric-coated Mycophenolate Sodiumdrug

1440mg/day for 6 months posttransplant