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 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT00274495
Eligibility Criteria:
Inclusion Criteria:
* Men and women at least 21 years of age.
* Positive serum hepatitis C RNA for at least 6 months.
* Naive to any therapy for hepatitis C infection.
* Significant steatosis or fat on the liver biopsy.
* Genotype 1 patients.
Exclusion Criteria:
* Subjects with decompensated liver disease.
* Hemoglobin \<12g/dl.
* WBC\<2,000mm3.
* ANC\<1,000mm3.
* Platelet count\<50,000/mm3.
* Creatinine\>1.5mg/dl.
* Albumin\<2.5g/dl.
* Bilirubin\>4mg/dl.
* HIV or hepatitis B co-infection.
* History of other liver disease besides fatty liver disease.
* History of unstable cardiac or cerebrovascular disease.
* History of significant psychiatric disorders.
* Alcohol or drug abuse within last year.
* Pregnant or lactating women or men whose sexual partner is pregnant or lactating.
* Taking of insulin or oral hypoglycemic agents within six months of the study.
* Uncontrolled thyroid disorder.
* History of malignancy within the past 5 years unless cured by surgery.
* History of autoimmune disorder or organ transplantations requiring immunosuppression.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT00274495
Study Brief:
Protocol Section:
NCT00274495