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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT06070051
Eligibility Criteria:
Inclusion Criteria:
1. Documented chronic HBV infection (eg, HBsAg+ ≥ 6 months with detectable HBsAg at screening)
2. Receipt of either entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate), or lamivudine for at least 12 months before screening with no reported antiviral resistance during this time; still on treatment at screening and expected to stay on therapy during the study period
3. Virally suppressed for \> 12 months (HBV DNA \< 40 IU/mL)
4. No clinical diagnosis of advanced liver fibrosis and/or cirrhosis
Exclusion Criteria:
1. History of hepatic decompensation, advanced fibrosis, or liver transplantation
2. History of hepatocellular carcinoma
3. History of risk factors for thrombosis and thrombocytopenia
4. Documented hepatitis A, hepatitis C, hepatitis D, hepatitis E, or HIV (or history of prior active disease)
5. Pregnant, nursing, or planning a pregnancy during the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06070051
Study Brief:
Protocol Section:
NCT06070051