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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT05423834
Eligibility Criteria:
Inclusion Criteria:
* Positive hepatitis B surface antigen (HBsAg) or documented history of CHB for 6 months or more; AND
* On TAF 25 mg daily as antiviral treatment for CHB (cases); OR
* On ETV 0.5 to 1.0 mg daily as antiviral treatment for CHB (controls)
Exclusion Criteria:
* Previous NA treatment prior to TAF or ETV
* Positive antibody against hepatitis C, D, or human immunodeficiency virus (anti-HCV, anti-HDV, or anti-HIV)
* Evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease).
* Moribund state including advanced/pre-terminal liver cancer or other non-hepatic cancers
* Non-hepatic cancer undergoing chemotherapy within last 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05423834
Study Brief:
Protocol Section:
NCT05423834