A 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients

CompletadoFase 2ClinicalTrials.gov

ID: NCT01128335Tipo: INTERVENTIONALInicio: 1 de abr de 2010Fin estimado: 1 de jul de 2012

Traducción no disponible, mostrando original

Resumen

This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Recipients of any race, 18 years or older
Recipients of primary de novo orthotopic liver transplant from a deceased donor
Recipients of a kidney with a cold ischemia time \< 30 hours
HCV-negative recipients

Criterios de exclusión

Prior organ/cellular transplant or multiple organ transplant
MELD-score \> 35
HCC \> Milan criteria
Donor age \< 12 years
Cold ischemia \> 15 hours
Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) or drugs with QT-prolonging properties

Intervenciones

drug

MMF(1000mg bid) + tacrolimus + standard of care medications

drug

sotrastaurin (200mg bid) + tacrolimus + standard of care medications

drug

sotrastaurin (200mg bid) + tacrolimus + standard of care medications

drug

sotrastaurin (300 mg bid) + tacrolimus + standard of care medications

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

San Martín, Buenos Aires, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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