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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
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.
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, China
Change in liver histological score from baseline
Time frame: 24 weeks after the end of treatment
Incidence of hepatocellular carcinoma (HCC)
Time frame: Week 48
Incidence of hepatic decompensation events
Time frame: Week 48
Change in liver stiffness measurement (LSM) from baseline
Evaluation is performed using liver imaging data such as liver MRI and histopathological data.
Time frame: Week 48,24 weeks after the end of treatment
Change in AST-to-Platelet Ratio Index (APRI) from baseline
Time frame: Week 48,24 weeks after the end of treatment
Change in Fibrosis-4 Index (FIB-4) from baseline
Time frame: Week 48,24 weeks after the end of treatment
HBsAg loss rate
Time frame: Week 48,24 weeks after the end of treatment
Seroconversion rate
Time frame: Week 48,24 weeks after the end of treatment
HBeAg loss rate
Time frame: Week 48,24 weeks after the end of treatment
HBV DNA undetectability rate
Time frame: Week 48,24 weeks after the end of treatment
HBV RNA undetectability rate
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Time frame: Week 48,24 weeks after the end of treatment
HBV RNA decline rate
Time frame: Week 48,24 weeks after the end of treatment