Status:
COMPLETED
Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 an...
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00821587
Start Date
June 1 2004
End Date
May 1 2008
Last Update
June 1 2023
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