Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Cyclosporine
* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tacrolimus<br>Tacrolimus | Drug: Tacrolimus<br>* 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.<br>* Other names: Prograf;|
| Active Comparator: Cyclosporine<br>Cyclosporine | Drug: Cyclosporine<br>* 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.<br>* Other names: Gengraf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Less Than 100 Hepatitis C Virus RNA Copies/mL | Number of Participants with Undetectable or Less than 100 copies/ml Hepatitis C Viral Level --defined as SVR -Sustained Virologic Response | 6 months after completion of interferon based therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C Post Liver Transplant