Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation - Full Text View

Sponsors and Collaborators:	University of Florida Novartis Pharmaceuticals
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00821587

Purpose

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.

Condition	Intervention	Phase
Hepatitis C	Drug: Cyclosporine Drug: Tacrolimus	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis C Liver Transplantation

Drug Information available for: Cyclosporine Cyclosporin Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

Further study details as provided by University of Florida:

Primary Outcome Measures:

HCV RNA PCR [ Time Frame: 6 months after completion of interferon based therapy ] [ Designated as safety issue: No ]

Enrollment:	38
Study Start Date:	June 2004
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1-: Active Comparator Tacrolimus	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.
2: Active Comparator Cyclosporine	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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821587

Sponsors and Collaborators

University of Florida

Novartis Pharmaceuticals

Investigators

Principal Investigator:

Roberto J Firpi-Morell, MD

University of Florida

More Information

No publications provided

Responsible Party:	University of Florida ( Roberto Firpi-Morell, MD )
Study ID Numbers:	20040658
Study First Received:	January 9, 2009
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00821587 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Florida:

Hepatitis C Post Liver Transplant

Study placed in the following topic categories:

Liver Diseases
Cyclosporine
Immunologic Factors
Clotrimazole
Miconazole
Tioconazole
Hepatitis, Viral, Human
Tacrolimus

Cyclosporins
Immunosuppressive Agents
Hepatitis
Virus Diseases
Digestive System Diseases
Antifungal Agents
Hepatitis C
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
RNA Virus Infections
Cyclosporine
Immunologic Factors
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hepatitis, Viral, Human
Enzyme Inhibitors
Tacrolimus

Immunosuppressive Agents
Cyclosporins
Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Therapeutic Uses
Antifungal Agents
Hepatitis C
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 06, 2009