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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00582738
• Date of registration: 12/12/2007
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy of Everolimus as Inhibitor of Fibrosis Progression in Liver Transplant Patients With Recurrence of Hepatitis C Viral Infection REVERT
• Scientific title: 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.
• Date of first enrolment: December 2007
• Target sample size: 43
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00582738
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Argentina

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Recurrent Hepatitis C

Intervention(s)

Drug: CsA-TAC (standard Treatment)

Drug: Everolimus

Primary Outcome(s)

Change From Baseline in Fibrosis Staging Score (Measured by the Ishak-Knodell Staging Score) Between Baseline and 24 Months Post-transplant. [Time Frame: baseline, 24 Months]

Secondary Outcome(s)

Comparison of Renal Function (Glomerular Filtration Rate [GFR] Calculated Using the Modification of Diet in Renal Disease Study Group [MDRD] Formula) Between Study Groups [Time Frame: 12 months, 24 months/EOS]

Comparison of the Effect of Both Regimens in the Necroinflammatory Grading Score (Ishak-Knodell) (Portal Inflammation) [Time Frame: baseline, 12 months, 24 months]

Number of Patients With Events (Progression to Cirrhosis, Retransplantation, HCV Related Death, First BPAR, Graft Loss)at 12 and 24 Months [Time Frame: 12 months, 24 months]

Percentage of Patients in Each Study Arm With Increase of =1 Point in the Ishak-Knodell Staging Score in Fibrosis [Time Frame: baseline to month 24]

Change From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Viral Load at 12 and 24 Months Post Randomization [Time Frame: baseline, 12 months, 24 months/EOS]

Comparison of the Effect of Both Regimens on the Inflammatory (Acti-test) and Fibrosis (Fibro-test) Components of Fibrosure, and on Fibrosis Area Assessed by Histomorphometry [Time Frame: baseline, 12 and 24 months]

Change From Baseline in Fibrosis Metavir Scoring at 12 and 24 Months Post Randomization [Time Frame: Baseline, 12 months, 24 months]

Percentage of Patients With Death, Graft Loss and Biopsy Proven Acute Rejection (BPAR) Between Study Groups [Time Frame: 24 Months]

Secondary ID(s)

CRAD001H2301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/09/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00582738