Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborator: Novartis Pharmaceuticals
• Treatments: Cyclosporine; Cyclosporins; Tacrolimus

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