Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

NCT ID: NCT00821587

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2008-05-31

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.

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrolimus

Tacrolimus

Group Type: ACTIVE_COMPARATOR

Tacrolimus

Intervention Type: 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.

Cyclosporine

Cyclosporine

Group Type: ACTIVE_COMPARATOR

Cyclosporine

Intervention Type: 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.

Interventions

Cyclosporine

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.

Intervention Type: DRUG

Tacrolimus

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.

Intervention Type: DRUG

Other Intervention Names

Gengraf; Prograf

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto J Firpi-Morell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Other Identifiers

20040658

Identifier Type: -

Identifier Source: org_study_id