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 @ 9:41 PM
Ignite Modification Date:
2025-12-24 @ 9:41 PM
NCT ID:
NCT06196632
Eligibility Criteria:
Inclusion Criteria:
* 1\. Sign an informed consent form;
* 2\. HBsAg (+), and the course of the disease exceeds six months;
* 3\. Age range from 16 to 70 years old;
* 4\. Female participants of childbearing age who had a negative pregnancy test before the trial and were able to take effective contraceptive measures;
* 5\. During the treatment period, within six months after the end of treatment, the patients agrees to use contraception
Exclusion Criteria:
* 1\. Patients with a known history of allergy to Peg-IFNα and NAs;
* 2\. Co-infection with other virus such as HAV, HCV, HDV, HEV, HIV, etc;
* 3\. Patients with liver cirrhosis or a Child Pugh score of 7 or above;
* 4\. History or evidence of liver disease caused by other factors (such as autoimmune liver disease, alcoholic liver disease, non-alcoholic fatty liver disease, drug-induced hepatitis, hepatolenticular degeneration, etc.);
* 5\. Pregnant or lactating women; Have a history of alcohol or drug abuse within the year prior to the trial enrollment screening;
* 6\. Neutrophil count\<1.5 × 109/L or hemoglobin\<100g/L or platelet count\<80 × 109/L; During the trial enrollment screening, serum creatinine was higher than the upper normal limit;
* 7\. A history of severe diseases in important organs and tissues such as the heart, brain, kidneys, retina, and muscles;
* 8\. Having a history of mental illness or a family history of mental illness, or a Hamilton Depression Scale score greater than 7 points;
* 9\. History of endocrine system or autoimmune diseases, such as thyroid disease, diabetes, systemic lupus erythematosus, sarcoidosis, autoimmune thrombocytopenic purpura, etc;
* 10\. History of malignant tumors;
* 11\. During the trial enrollment screening, suspicious liver malignant tumors were detected by ultrasound, or AFP was greater than 100ng/mL or AFP cannot remain stable within 3 months prior to the experiment;
* 12\. Has a history of important organ transplantation;
* 13\. Other diseases that researchers believe are not suitable for inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
70 Years
Study:
NCT06196632
Study Brief:
Protocol Section:
NCT06196632