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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT07203118
Eligibility Criteria:
Inclusion Criteria:
1）Age between 18 to 65 years old (inclusive), regardless of gender. 2) Meets diagnostic criteria for chronic hepatitis B (documented HBsAg positivity or HBV DNA positivity for more than 6 months, or confirmed by liver biopsy histopathology).
3)No prior treatment with any nucleos(t)ide analogue oral antiviral therapy; or, previous treatment with any nucleos(t)ide analogue must have ended at least 6 months prior to baseline.
4\) Any interferon therapy (both pegylated and non-pegylated) must be completed at least 1 year prior to baseline visit.
5\) Willing to use effective non-pharmacological contraception during the trial period.
Exclusion Criteria:
1. Hypersensitive to the study drug, its metabolites or any excipient in its formula;
2. With previous or present clinical hepatic decompensation (e.g., ascites, hepatic encephalopathy or varicose vein haemorrhage)
3. Complicated with liver diseases, including chronic alcoholic hepatitis, drug-induced hepatitis, etc.
4. Complicated with HCV, HIV or HDV infections
5. Documented resistance to the antiviral drug (Tenofovir).
6. Any cardiovascular, hematologic,pulmonary or nervous diseases deemed serious by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07203118
Study Brief:
Protocol Section:
NCT07203118