A Randomized, Controlled, Open Label, Two Arms, Exploratory Study to Evaluate the Effect of Everolimus on Histologically Assessed Fibrosis Progression (Ishak-Knodell) in Liver Transplant Recipients With Recurrent Hepatitis C Viral Infection as Compared to Standard Treatment.

TerminadoFase 2ClinicalTrials.gov

ID: NCT00582738Tipo: INTERVENTIONALInicio: 1 de dic de 2007Fin estimado: 1 de ene de 2010

Neumología Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

This study will assess the efficacy of everolimus as an inhibitor of fibrosis progression in liver transplant patients who have a recurrence of hepatitis C viral infection in the transplant

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Male or female patients 18 - 65 years of age
Recipients of deceased or living donors
Patients who had undergone primary liver transplantation at least 6 months before enrolment
Recurrent Hepatitis C viral infection and histologically confirmed liver fibrosis (stage I-IV in the Ishak-Knodell scale) obtained at baseline or within the previous 6 months to the date of enrolment
Patients receiving tacrolimus or cyclosporine micro-emulsion with or without - Mycophenolic acid (MPA), with or without steroids.
Absence of acute rejection episodes within the previous 6 months to the date of enrolment
Patient in whom an allograft biopsy will not be contraindicated
Patient willing and capable of giving written informed consent for study participation and able to participate in the study for 24 months
Patients with Hepatocellular carcinoma (HCC) within the University California, San Francisco (UCSF) Criteria and no recurrence for at least 18 months after OLT.

Criterios de exclusión

Recipients of multiple organ transplants or patients who have undergone retransplantation
Current biliary complications
History of drug or alcohol abuse within 1 year before enrolment
Patients treated with anti-hepatitis C virus treatment at the time of enrollment or within the previous month to the date of enrolment
Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
Patients with Leukocyte count (WBC) \< 3000/mm3, platelet count \< 75000/mm3 or Hemoglobin (Hb) \< 8 g/dl
Patients with proteinuria \>1g/24 hours
Patient with a current severe systemic infection

Intervenciones

drug

CsA-TAC (standard Treatment)

Continuation of current immunosuppressive regimen (continuation of CNI with or without MPA, with or without steroids) / no everolimus introduction.

drug

Everolimus

Hepatitis C recurrence after orthotopic liver transplantation (OLT)

Ubicaciones

Novartis Investigative site

Buenos Aires, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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