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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT00556504
Eligibility Criteria:
Inclusion Criteria:
* HCV strain confirmed as genotype I;
* Elevated ALT (≥1.5 x upper limit of normal)during last 6 months
* Females of childbearing potential with a negative serum pregnancy test
* Subject must be willing to sign a written informed consent
* Subject must be willing and able to adhere to dose and visit schedule.
Exclusion Criteria:
* Serum AFP levels \> 400 ng/ml
* Liver biopsy within 12 months prior to study entry showed liver cirrhosis with METAVIR system fibrosis score of 3-4, or hepatocellular carcinoma (HCC);
* Co-infection with hepatitis B virus (HBV);
* Anti-HIV positive;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT00556504
Study Brief:
Protocol Section:
NCT00556504