Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

This is a randomized, single-center controlled study comparing two different immunosuppression regimens (CsA and TAC) in patients with recurrent HCV after LT undergoing antiviral therapy for HCV.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males and females age 18 years and older
HCV RNA positive by PCR after liver transplantation
Elevated ALT at any time point after liver transplantation
Protocol liver biopsy (standard of care) consistent with Stage greater than or equal to 2 of Ishak fibrosis score after liver transplantation
Able to provide written informed consent
Willing to practice acceptable birth control during the study period.

Exclusion criteria

Decompensated Cirrhosis
hemoglobin < 12 g/dl
WBC < 3,500/cubic mm
Platelets < 75,000/cubic mm
Human immunodeficiency virus infection
Pregnancy
Positive HbsAg
History of coronary artery disease, history of seizure disorder, poorly controlled autoimmune conditions, thyroid dysfunction, diabetes mellitus, major psychosis, intolerance to previous interferon-based therapy other than anemia or neutropenia
History of suicidal ideation or suicidal attempts
Creatinine > 2.0 mg/dl
Severe non-hepatic illnesses

Treatment and study plan

cyclosporine

Drug

Patients randomized to CsA had TAC discontinued and were treated with CsA at a dose of 2.0-4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150-200 ng/ml.

Other names: Gengraf

Tacrolimus

Drug

Patients receiving TAC were treated with a dose of 0.08-0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10-15 ng/ml for the first month post-transplant followed by 5-10 ng/ml thereafter. Immunosuppression was typically tapered to monotherapy (TAC alone) within 4-6 months of transplantation.

Other names: Prograf

Primary outcomes

Number of Participants With Less Than 100 Hepatitis C Virus RNA Copies/mL

Time frame: 6 months after completion of interferon based therapy

Number of Participants with Undetectable or Less than 100 copies/ml Hepatitis C Viral Level --defined as SVR -Sustained Virologic Response

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

Novartis Pharmaceuticals

Registry information

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Jan 13, 2009
Registry last updated: Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed