Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

Phase 4

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Tacrolimus; Drug: Cyclosporine

• Registration Number: NCT00821587
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-13
• Results First Submitted: 2011-08-04
• Results First Submitted QC: 2011-11-02
• Results First Posted: 2011-12-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus	Tacrolimus	Tacrolimus
Cyclosporine	Cyclosporine	Cyclosporine

Primary Outcome Measures

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