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Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C

A Multi-center, Randomized, Open Label, Controlled Study to Compare the Sustained Virological Response During Treatment With Neoral or Tacrolimus in Maintenance Liver Transplant Recipients Treated With Pegylated Interferon and Ribavirin for Recurrent Hepatitis C

NCT00938860•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will assess the rates of Sustained Virological Response following anti-viral therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with recurrent Hepatitis C and treated with Neoral or tacrolimus.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Liver transplantation performed at least 6 months and up to 5 years prior randomization and due to HCV cirrhosis, with or without pre-transplant hepatocellular carcinoma (HCC) within Milan or UCSF criteria
•Immunosuppresive regimen based on tacrolimus b.i.d.- (twice or once daily) for at least 6 months prior randomization
•Diagnosis of HCV genotypes 1 or 4 infection prior to transplantationconfirmed at screening
•Indication of treatment with Peg-IFN and ribavirin due to histological evidence of chronic HCV infection defined as a fibrosis stage equal or greater than 1 using the Ishak-Knodell scoring system (IK ≥1) in a liver biopsy performed at screening or up to 4 months prior to randomization.

Exclusion Criteria

•Serum creatinine \>150 μmol/L (1.6 7 mg/dL) or eGFR \< 50 ml/min (4-variable Modification of Diet in Renal Disease \[MDRD Cockcroft-Gault formula\])
•Multi-organ transplant recipients
•Recent episode of steroid-treated acute rejection (AR) within 3 months prior to randomization, or \>1 episode of steroid-treated AR in the last 6 months, or any number of steroid-resistant AR episodes in the last 6 months including evidence of chronic rejection or ductopenia
•Evidence of conditions that could cause graft dysfunction other than HCV infection
•Patients with signs of decompensated liver disease, defined as presence of ascites, variceal bleeding, encephalopathy or deteriorated hepatic synthetic function (albumin \<3.5g/dL or, total direct bilirubin \>1.5mg/dL or, INR \>1.5)
•Co-infection with HIV or Hepatitis B (defined as HBsAg-positive) at screening
•Use of mTOR inhibitors (everolimus or sirolimus) in the 6 months prior to screening
•Antiviral treatment for HCV administered at any time after liver transplantation
•Patients on daily doses of corticosteroids higher than 5 mg/day
•Patients with fibrosing cholestatic hepatitis
+3 more criteria

Locations (45)

Novartis Investigative Site

Phoenix, Arizona, United States

Novartis Investigative Site

Palo Alto, California, United States

Novartis Investigative Site

San Francisco, California, United States

Novartis Investigative Site

Gainesville, Florida, United States

Novartis Investigative Site

Chapel Hill, North Carolina, United States

Novartis Investigative Site

Oklahoma City, Oklahoma, United States

Novartis Investigative Site

Houston, Texas, United States

Novartis Investigative Site

Houston, Texas, United States

Novartis Investigative Site

Madison, Wisconsin, United States

Novartis Investigative Site

Brussels, Belgium

Key Dates

Start Date

September 1, 2009

Primary Completion Date

May 1, 2013

Completion Date

May 1, 2013

Last Updated

May 22, 2015

Enrollment

ACTUAL participants

Conditions

Hepatitis CLiver Transplantation

Interventions

cyclosporin (Neoral)

DRUG

tacrolimus (Prograf)

DRUG

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

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RECRUITINGNA

Rectus-Intercostal Fascial Plane Block for Liver Transplantation Donors

NCT07233096

Liver TransplantationLiving Donor+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C

Inclusion Criteria

Exclusion Criteria

Implementing Low-Barrier HCV Treatment in a Jail Setting

Rectus-Intercostal Fascial Plane Block for Liver Transplantation Donors

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