Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Comparison to Mycophenolate Mofetil (MMF) in de Nove Heart Patients

Novartis

Status and phase

Completed

Phase 4

Conditions

Heart Transplantation

Treatments

Drug: Enteric-coated Mycophenolate Sodium

Study type

Interventional

Funder types

Industry

Identifiers

CERL080A2401

Details and patient eligibility

About

This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.

Enrollment

162 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Male or female cardiac patients 18-65 years old undergoing primary heart transplantation treated with CS-ME and corticosteroids as basic immunosuppression.
Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion criteria

Patients with donor hearts greater than 60 years of age and/or with cold ischemia time of more than 6 hours and/or donor hearts which have obvious coronary disease or are known to have heart disease at time of transplant.
Patients on Left Ventricular Assist Device who have received any immunotherapy prior to transplantation or who are scheduled to receive immunotherapy thereafter.
Patients with Panel Reactive Antibodies (PRA) 25%.
Patients with serum creatinine 3.0mg/dL..
Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
Patients with a history of significant coagulopathy or medical condition requiring long term anti-coagulation after transplantation (low aspirin treatment is allowed).

Other protocol-defined inclusion/exclusion criteria may apply