This is a real-world, prospective, multicenter, non-randomized, controlled study. It aims to investigate the efficacy and safety of pegylated interferon α-2b (PEG IFN α-2b) monotherapy versus its combination with nucleos(t)ide analogs (NAs) regarding hepatitis B surface antigen (HBsAg) clearance in interferon-experienced patients with chronic hepatitis B (CHB). Subjects will receive either interferon-based therapy or NAs monotherapy based on their personal willingness and physicians' professional recommendations, with a uniform 48-week treatment course for all enrolled patients.
Study Type
OBSERVATIONAL
Enrollment
10,000
Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered.
Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered.
Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Percentage of subjects with undetectable HBsAg
Time frame: Week 48
Percentage of subjects with undetectable HBV DNA
Time frame: Week 48
Number of patients with a decrease in HBV DNA from baseline
Time frame: Week 1-48
Proportion of subjects with HBV DNA below the lower limit of detection
Time frame: Week 1-48
Number of patients with a decrease in HBsAg from baseline
Time frame: Week 1-48
Proportion of HBsAg seroclearance
Time frame: Week 1-48
Proportion of HBsAg seroconversion
Time frame: Week 1-48
Proportion of HBeAg seroclearance
Time frame: Week 1-48
Proportion of HBeAg seroconversion
Time frame: Week 1-48
Serious adverse events
Time frame: Week 1-48
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