Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

University of Florida

Status and phase

Completed

Phase 4

Conditions

Hepatitis C

Treatments

Drug: Cyclosporine

Drug: Tacrolimus

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00821587

20040658

Details and patient eligibility

About

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.

Full 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.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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