A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients

Astellas

Status and phase

Completed

Phase 4

Conditions

Liver Transplantation

Treatments

Drug: Myfortic

Drug: Advagraf

Drug: Prograf

Study type

Interventional

Funder types

Industry

Identifiers

NCT01018914

ADVLTx-0901-TW

Details and patient eligibility

About

To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.

Enrollment

44 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is a primary liver transplant recipient
Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant
Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
Patient must receive 1st dose of study drug within 24 hours of pre-transplantation

Exclusion criteria

Patient has previously received or is receiving an organ transplant other than a liver
Patient currently requires dialysis
Patient has received a liver transplant from a non-heart beating donor
Patient has received an ABO incompatible donor liver
Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
Patient has fulminant hepatic failure, unless hemodynamically stable
Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives
Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
Patient has a known hypersensitivity to tacrolimus, enteric-coated mycophenolate sodium or corticosteroids
Patient is pregnant or lactating