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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00167557 |
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Date of registration:
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09/09/2005 |
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Primary sponsor: |
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Public title:
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Orthotopic Liver Transplant (OLT) Recipients With Hepatitis C Virus (HCV) Under Preemptive Treatment
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Scientific title:
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Tacrolimus Monotherapy in OLT Recipients With HCV Under Preemptive Treatment With Interferon and Ribavirin |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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75 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00167557 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Hadar J Merhav, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Texas Health Science Center, Houston |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Adult male or female patients between 18 and 70 years of age
2. All liver transplant patients with a positive HCV RNA by PCR within 30 days after
transplant.
3. No evidence of acute or chronic rejection within 4 weeks of enrollment
4. Compensated liver disease according to the following criteria:
- Hemoglobin > 10 gm/dL;
- Neutrophil count > 1,000/mm3;
- Platelet count > 50,000/mm3;
- Serum creatinine < 2.0 mg/dL.
5. Documentation of adequate contraception in females and males sexually active or of
childbearing potential.
Exclusion Criteria:
1. Hypersensitivity to alpha interferon and/or ribavirin
2. Previous treatment with interferon and/or ribavirin post liver transplantation
3. HIV
4. Autoimmune hepatitis
5. Active alcohol or substance abuse
6. Non compliance
7. Hemoglobinopathies or hemolytic anemia
8. Clinical significant retinal abnormalities
9. Decompensated cardio-vascular, endocrine, pulmonary, renal, immune, metabolic,
dermatologic or psychiatric illness
10. Re-transplantation
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatitis C
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Intervention(s)
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Drug: Pegylated Interferon
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Drug: Ribavirin
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Procedure: Liver Biopsy
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Primary Outcome(s)
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Viral clearance after liver transplantation
[Time Frame: 3 yrs. post liver transplant]
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Secondary Outcome(s)
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histological progression of fibrosis and inflammation
[Time Frame: 3 yrs. post liver transplant]
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rate of rejection on HCV treatment
[Time Frame: 3 yrs post liver transplant]
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Secondary ID(s)
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Astellas Pharma
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FHIprojectno.JK-04-002
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HSC-MS-04-0346
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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