This study is a multicenter, randomized, prospective trial designed to evaluate the efficacy and safety of pegylated interferon α-2b (Peg-IFN-α2b) combined with nucleos(t)ide analogues (NAs) versus NAs monotherapy in patients with compensated hepatitis B cirrhosis. A total of 30 patients with compensated HBV-related cirrhosis will be enrolled and randomized in a 2:1 ratio to either Experimental Group 1 (n=20) or Experimental Group 2 (n=10). The treatment regimens consist of Peg-IFN-α2b combined with NAs (ETV/TAF/TMF/TDF) or NAs (ETV/TAF/TMF/TDF) monotherapy.
Clinical diagnosis of compensated HBV-related liver cirrhosis (Child-Pugh class A or B);
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;
Aged 18 to 60 years (inclusive), any gender;
Female subjects of childbearing potential must have a negative pregnancy test at screening;
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;
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;
Pregnancy, lactation, or intention to become pregnant during the study period;
Known or suspected allergy to the investigational product(s) or any of its excipients;
Parallel
Peginterferon alfa-2b combined with NAs
DrugSubcutaneous 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
DrugTreatment 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.
Change in liver histological score from baseline
Incidence of hepatocellular carcinoma (HCC)
Incidence of hepatic decompensation events
Change in liver stiffness measurement (LSM) from baseline
Evaluation is performed using liver imaging data such as liver MRI and histopathological data.
Change in AST-to-Platelet Ratio Index (APRI) from baseline
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