Efficacy of Everolimus as Inhibitor of Fibrosis Progression in Liver Transplant Patients With Recurrence of Hepatitis C Viral Infection
Condition: Recurrent Hepatitis C
MeSH terms: Infections; Hepatitis A; Hepatitis C; Virus Diseases; Hepatitis; Recurrence; Fibrosis; Disease Progression
Intervention: CsA-TAC (standard Treatment); Everolimus
Intervention description: Continuation of current immunosuppressive regimen (continuation of CNI with or without MPA, with or without steroids) / no everolimus introduction.; Hepatitis C recurrence after orthotopic liver transplantation (OLT)
Intervention MeSH terms: Everolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fibrosis progression; recurrent hepatitis C; viral infection; liver transplant recipients; everolimus; Hepatitis C recurrence after orthotopic liver transplantation (OLT)

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
    

Eligibility 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.