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 @ 5:16 PM
Ignite Modification Date:
2025-12-24 @ 5:16 PM
NCT ID:
NCT07079150
Eligibility Criteria:
Inclusion Criteria:
* Meet the criteria for a family cluster of unfavorable prognoses associated with HBV infection: that is, patients with HBV infection in two consecutive generations of blood relatives, and at least one patient with cirrhosis or HCC in two or more generations of blood relatives;
* Chronic HBV-infected individuals from families with unfavorable prognoses clustering (meeting either (1)+(2) or (1)+(3) criteria): (1) Positive for HBsAg for more than 6 months; (2) Treated with nucleos(t)ide analogs (NAs); (3) Compensated cirrhosis due to hepatitis B (for details, see the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)");
* A negative pregnancy test within 24 hours before the first administration of medication in the treatment group (for women of childbearing age);
* No contraindications for interferon treatment.
Exclusion Criteria:
* Patients diagnosed with liver cancer or other systemic tumors before treatment;
* Patients with contraindications to Peg IFN α-2b use (for details, see the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)");
* Peripheral blood counts: WBC \< 3.0 × 10\^9/L, PLT \< 70 × 10\^9/L;
* Liver function: ALT \> 5 × upper limit of normal (ULN), TBIL \> 2 × ULN; Individuals planning to receive organ transplantation or who have already undergone organ transplantation;
* Those allergic to interferon or with any contraindication listed in the product information;
* Any other conditions deemed unsuitable for enrollment by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07079150
Study Brief:
Protocol Section:
NCT07079150