NCT01467011

Myfortic, Prograf, and Corticosteroids in de Novo Liver Transplantation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: R. Mark Ghobrial, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Myfortic is approved for use in kidney transplant recipients, and has been prescribed by doctors for liver transplant recipients. No study has been reported to date evaluating the pharmacokinetics of Myfortic in new liver transplant recipients who also take Prograf and corticosteroids. During this six month study, a series of blood samples will be obtained after subjects take Myfortic, Prograf, and corticosteroids.

Conditions

• End Stage Liver Disease

Interventions

Type	Name	Description
DRUG	Enteric-coated Mycophenolate Sodium	1440mg/day for 6 months posttransplant

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-11-08
• Last updated: 2018-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study