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Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Cyclosporine

Tacrolimus

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C Post Liver Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Tacrolimus

Cyclosporine

Arm Description

Tacrolimus

Cyclosporine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00821587

First Posted

January 9, 2009

Last Updated

May 30, 2023

Sponsor

University of Florida

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00821587

Brief Title

Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

Official Title

Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

Hepatitis C Post Liver Transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tacrolimus

Arm Type

Active Comparator

Arm Description

Tacrolimus

Arm Title

Cyclosporine

Arm Type

Active Comparator

Arm Description

Cyclosporine

Intervention Type

Drug

Intervention Name(s)

Cyclosporine

Other Intervention Name(s)

Gengraf

Intervention Description

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

Intervention Name(s)

Tacrolimus

Other Intervention Name(s)

Prograf

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Number of Participants with Undetectable or Less than 100 copies/ml Hepatitis C Viral Level --defined as SVR -Sustained Virologic Response

Time Frame

6 months after completion of interferon based therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roberto J Firpi-Morell, MD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

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