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Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00821587
Recruitment Status : Completed
First Posted : January 13, 2009
Results First Posted : December 8, 2011
Last Update Posted : December 8, 2011
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Cyclosporine Drug: Tacrolimus Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation
Study Start Date : June 2004
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Hepatitis C Viral Level [ Time Frame: 6 months after completion of interferon based therapy ]
    Undetectable or <100 COPIES/ML


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821587


Sponsors and Collaborators
University of Florida
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Roberto J Firpi-Morell, MD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00821587    
Other Study ID Numbers: 20040658
First Posted: January 13, 2009    Key Record Dates
Results First Posted: December 8, 2011
Last Update Posted: December 8, 2011
Last Verified: November 2011
Keywords provided by University of Florida:
Hepatitis C Post Liver Transplant
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Cyclosporine
 Tacrolimus
Cyclosporins
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents