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 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT05793268
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 20 years
2. Chronic hepatitis B virus infection (defined as positive HBsAg for ≥ 6 months)
3. Entecavir or tenofovir (either tenofovir disoproxil fumarate or tenofovir alafenamide) for at least two years and still on therapy at screening for this trial.
4. Fulfillment of the stopping rules recommended by the Asian-Pacific guidelines 2016:
* For patients with positive HBeAg prior to their antiviral treatment, HBeAg seroconversion needs to be documented and followed by consolidation treatment for at least one year). Besides, serum ALT is within normal limits and HBV DNA is undetectable.
* For those with negative HBeAg prior to the antiviral therapy, undetectable HBV DNA documented on three separate occasions (at least 6 months apart)
5. At screening for this study, HBsAg serology is positive, HBeAg negative, and HBV DNA undetectable in serum.
Exclusion Criteria:
1. Liver cirrhosis (either clinical or pathological diagnosis) at screening
2. Serious underlying disease (with valid certification of catastrophic illness) at screening
3. Manifestations and concerns of hepatic decompensation, including serum bilirubin \>2mg/dL and/or prolongation of prothrombin time \> 3 seconds at screening
4. Hepatitis C virus (if anti-HCV serology is positive, confirmation with detectable HCV RNA is required), human immunodeficiency virus (HIV) or hepatitis delta virus (HDV) coinfection at screening.
5. Prior history of any malignancy including liver cancer
6. Prior history of any organ transplantation
7. Prior history of drug resistance to any Nuc agent
8. Any patient condition that the treating physician deems inappropriate for enrollment in this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT05793268
Study Brief:
Protocol Section:
NCT05793268