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:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT03920618
Eligibility Criteria:
Inclusion Criteria:
1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
2. Age from 12 to 65 years old;
3. Serum total bilirubin level \> 10 times upper limit of normal;
4. Prothrombin time activity \< 40% or prothrombin time international ratio \> 1.5；
5. Do not receive nucleotide/nucleoside analogues treatment in the past half year.
Exclusion Criteria:
1. Other active liver diseases;
2. Hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions;
7. Using glucocorticoid;
8. Patients can not follow-up;
9. Investigator considering inappropriate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
65 Years
Study:
NCT03920618
Study Brief:
Protocol Section:
NCT03920618