Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT00167557
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00167557
Study Brief:
Protocol Section:
NCT00167557