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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Recurrent Hepatitis C

Treatments: Drug: CsA-TAC (standard Treatment); Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00582738

CRAD001H2301

Details and patient eligibility

About

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

Enrollment: 43 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

43 participants in 2 patient groups

CsA-TAC

Active Comparator group

Description:

Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor \[CNI\] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)\[MPA\], with or without steroids) / no everolimus introduction.

Treatment:

Drug: CsA-TAC (standard Treatment)

everolimus

Experimental group

Description:

Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.

Treatment:

Drug: Everolimus