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:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
NCT ID:
NCT06357806
Eligibility Criteria:
Inclusion Criteria:
1. 18 - 65 years old;
2. Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months);
3. Treatment with NAs (ETV, TDF or TAF）at least 1 years and continue NAs therapy during screening;
4. HBV DNA and HBeAg turn negative after NAs treatment;
5. HBsAg ranged 200-1000 IU/ml.
Exclusion Criteria:
1. Cirrhosis;
2. platelet count \< 90×10\^9/L, WBC count \< 3.0×10\^9/L, neutrophil count \< 1.3×10\^9/L, ALT \> ULN（40U/L）, total bilirubin \> 2ULN;
3. History of or suspicion of hepatocellular carcinoma
4. Patients received interferon therapy within 12 months;
5. Patients received immunosuppressive therapy or other therapy influenced study within 12 months;
6. Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections;
7. Alcohol or drug abuse/dependence;
8. Investigator judges that the participants are not suitable for this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06357806
Study Brief:
Protocol Section:
NCT06357806