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 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT02476695
Eligibility Criteria:
Inclusion Criteria:
* Subjects with age 18-65 years, both gender
* Subjects with history of HBV or HBsAg positive \> 6 months up to enrollment
* Subjects with qualified liver biopsy specimens within three months (before or after) of Fibrotouch examination for pathological staging
* Subjects without chemical therapy history of powerful medicine to lower enzyme in the two weeks before blood biochemistry tests (e.g. dimethyl diphenyl bicarboxylate and bicyclol)
* Subjects must agree and sign the informed consent form
Exclusion Criteria:
* Subjects who are unable or unwilling to sign informed consent form
* Subjects who have merger of hepatitis C, alcohol and non-alcoholic fatty liver diseases, autoimmune liver diseases, inherited metabolic liver diseases, biliary systemic diseases or liver and gall parasitic diseases
* Subjects who have other serious chronic disorders or history of malignancy
* Subjects with ALT ≥5 ULN in the past 1 month
* Subjects with WBC\<3.5×10\^9/L, PLT\<60×10\^9/L, PTA\<60%
* Subjects with DBIL≥1.5 ULN
* Subjects with decompensated cirrhosis (especially the people with ascites)
* Pregnant or lactating women, or women who has a pregnant plan and don't want to birth control in the study period
* Subjects who have wound on the right upper abdomen recently
* Subjects who have various space-occupying tumor or cyst in right liver
* Subjects who have none or limited legal capacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02476695
Study Brief:
Protocol Section:
NCT02476695