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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT05357235
Eligibility Criteria:
Inclusion Criteria:
* Aged from 16 to 60;
* The positive time of HBsAg was 6 months,
* 48 weeks of treatment with ETV, TDF or TAF, including HBeAg positive and negative patients;
* High sensitive reagent was used to confirm that the low level of serum HBV DNA was 20 IU / ml-2000 IU / ml.
* Good compliance and sign informed consent.
Exclusion Criteria:
1. Patients with decompensated liver cirrhosis or previous decompensated liver cirrhosis;
2. Those who have used interferon within 6 months;
3. at the same time, it is associated with other virus infections, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, AIDS virus, etc;
4. in addition to hepatitis B, there are other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, neurological, digestive, severe metabolic diseases (such as uncontrolled hyperthyroidism, serious complications of diabetes and adrenal diseases), immune deficiency diseases, and severe infections;
5. Active or suspected malignant tumor or history of malignant tumor;
6. 6 months before enrollment or currently receiving corticosteroids, immunosuppressants and chemotherapeutic drugs;
7. Complicated with alcoholic liver disease, autoimmune liver disease and other liver diseases;
8. HBV resistant patients;
9. Other situations that the researcher believes are not suitable for inclusion.
PegIFN α Treatment contraindications:
1. Prohibited for known pairs α- Patients who are allergic to interferon, E. coli products, polyethylene glycol or any component of this product;
2. It is forbidden to be used in patients with autoimmune hepatitis;
3. Pregnant and lactating women;
4. Central nervous system diseases, mental diseases, uncontrolled epilepsy, non withdrawal of alcohol / drug abuse, decompensated liver cirrhosis, symptomatic heart disease, uncontrolled autoimmune diseases and severe thyroid function diseases;
5. Absolute neutrophil count before treatment ≤ 1.0 × 109 / L, platelet ≤ 80 × 109/L。
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
60 Years
Study:
NCT05357235
Study Brief:
Protocol Section:
NCT05357235