A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis

• Peginterferon alfa-2b combined with NAs (Drug): Subcutaneous injection therapy,Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status.
• NAs (Drug): Treatment will continue for 48 weeks, with follow-up assessments conducted every 12 weeks. The dosage will be adjusted based on the patient's disease status.

Primary outcomes

• Change in liver histological score from baseline [24 weeks after the end of treatment]

Secondary outcomes

• Incidence of hepatocellular carcinoma (HCC) [Week 48]
• Incidence of hepatic decompensation events [Week 48]
• Change in liver stiffness measurement (LSM) from baseline [Week 48,24 weeks after the end of treatment]: Evaluation is performed using liver imaging data such as liver MRI and histopathological data.
• Change in AST-to-Platelet Ratio Index (APRI) from baseline [Week 48,24 weeks after the end of treatment]
• Change in Fibrosis-4 Index (FIB-4) from baseline [Week 48,24 weeks after the end of treatment]
• HBsAg loss rate [Week 48,24 weeks after the end of treatment]
• Seroconversion rate [Week 48,24 weeks after the end of treatment]
• HBeAg loss rate [Week 48,24 weeks after the end of treatment]
• HBV DNA undetectability rate [Week 48,24 weeks after the end of treatment]
• HBV RNA undetectability rate [Week 48,24 weeks after the end of treatment]
• HBV RNA decline rate [Week 48,24 weeks after the end of treatment]

Sex: All, ages: 18 Years to 60 Years

Inclusion Criteria:

1. Clinical diagnosis of compensated HBV-related liver cirrhosis (Child-Pugh class A or B);
2. The subject is able to understand and comply with the content, requirements, and restrictions of the protocol, is willing and able to complete the study per protocol requirements, fully understands the potential adverse reactions, and voluntarily provides written informed consent prior to study initiation;
3. Aged 18 to 60 years (inclusive), any gender;
4. Female subjects of childbearing potential must have a negative pregnancy test at screening;
5. Subjects (including their partners) must voluntarily use effective non-drug contraception from prior to dosing until six months after discontinuation of the study drug and have no plan to donate sperm or ova; or subjects (including their partners) are of non-childbearing potential (surgically sterilized or postmenopausal).

Exclusion Criteria:

1. Decompensated liver cirrhosis, hepatic failure, or hepatocellular carcinoma; presence of other liver diseases such as fatty liver disease, alcoholic liver disease, drug-induced liver injury, autoimmune liver disease, or Wilson's disease;
2. History of clinically significant diseases of the cardiovascular, hematological and lymphatic, respiratory, urinary, endocrine, immune, psychiatric, or nervous systems (e.g., epilepsy), ophthalmic diseases, or thyroid-related disorders;
3. Pregnancy, lactation, or intention to become pregnant during the study period;
4. Known or suspected allergy to the investigational product(s) or any of its excipients;
5. Participation in any other interventional clinical trial within 3 months prior to screening or planning to participate in another clinical trial during the study;
6. Any other condition considered by the investigator to be inappropriate for participation in the study.

• Wenqi Huang, Principal investigator, Xiamen Humanity Hospital