A 12-month, Single-blind, Randomized, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of ERL080A Compared With MMF in de Novo Heart Recipients
CompletadoFase 4ClinicalTrials.gov
ID: NCT00574743Tipo: INTERVENTIONALInicio: 1 de ene de 2002
Traducción no disponible, mostrando original
Resumen
This study will evaluate the safety and efficacy of EC-MPS (ERL080) in comparison to MMF in de novo heart recipients.
Elegibilidad
Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL
Criterios de inclusión
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.
Criterios de exclusión
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).
Intervenciones
drug
Enteric-coated Mycophenolate Sodium
Ubicaciones
Argentina
Buenos Aires, Argentina
Site 1: X5000BJH
Córdoba, Argentina
Patrocinadores
PrincipalNovartis Pharmaceuticals
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