Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

Hepatitis C Clinical Trial

Official title:

Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821587
• Other study ID #: 20040658
• Status: Completed
• Phase: Phase 4
• Start date: June 2004
• Est. completion date: May 2008

Study information

• Verified date: May 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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