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

NCT ID: NCT00582738

Last Updated: 2012-09-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Recurrent Hepatitis C

Keywords

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Fibrosis progression recurrent hepatitis C viral infection liver transplant recipients everolimus Hepatitis C recurrence after orthotopic liver transplantation (OLT)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CsA-TAC

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.

Group Type ACTIVE_COMPARATOR

CsA-TAC (standard Treatment)

Intervention Type DRUG

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

everolimus

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

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Hepatitis C recurrence after orthotopic liver transplantation (OLT)

Interventions

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CsA-TAC (standard Treatment)

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

Intervention Type DRUG

Everolimus

Hepatitis C recurrence after orthotopic liver transplantation (OLT)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative site

Buenos Aires, , Argentina

Site Status

Countries

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Argentina

Other Identifiers

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CRAD001H2301

Identifier Type: -

Identifier Source: org_study_id