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Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00821587
First received: January 9, 2009
Last updated: November 2, 2011
Last verified: November 2011
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Hepatitis C Viral Level [ Time Frame: 6 months after completion of interferon based therapy ] [ Designated as safety issue: No ]
    Undetectable or <100 COPIES/ML


Enrollment: 39
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
Active Comparator: Tacrolimus
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.
Other Name: Prograf
Active Comparator: Cyclosporine
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.
Other Name: Gengraf

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
ClinicalTrials.gov Identifier: NCT00821587     History of Changes
Other Study ID Numbers: 20040658
Study First Received: January 9, 2009
Results First Received: August 4, 2011
Last Updated: November 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Hepatitis C Post Liver Transplant

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Cyclosporins
Cyclosporine
 Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013