Efficacy of Everolimus as Inhibitor of Fibrosis Progression in Liver Transplant Patients With Recurrence of Hepatitis C Viral Infection

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Other protocol defined inclusion/exclusion criteria may apply.