Previous clinical practice and exploratory studies suggest that some patients who have not achieved functional cure in the first round of interferon therapy can achieve HBsAg clearance by interferon retreatment (intermittent therapy), which can reduce the occurrence of complications such as liver fibrosis, liver cirrhosis and liver cancer, and its clinical benefit is expected to be higher than that of NAs monotherapy. This study is aimed to conduct a large-scale, multicenter, prospective study to confirm the benefit of peginterferon-based therapies in these populations. It expected to enroll about 2000 patients with chronic hepatitis B who have received prior interferon therapy and achieved a good response but without function cure, patients receive either interferon-based therapy or NAs monotherapy, according to their wishes and doctors' professional recommendations, with a ratio of 2:1 between the two groups, and all patients treated for 48 weeks. The HBsAg clearance rate before and after treatment, safety, etc. will be analyzed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,016
Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks. If the baseline HBV DNA is higher than the minimum detection limit (using high-sensitivity kit), combined with nucleos(t)ide analogs (NAs) is recommended.
First-line NAs (e.g. Entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), tenofovir amibufenamide (TMF)), one tablet a day, take orally, for 48 weeks.
Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGProportion of patients with HBsAg below the lower limit of detection.
Time frame: Week 48
Decrease of HBV DNA levels at week 48 compared to baseline.
Time frame: Week 48
Proportion of patients with HBV DNA below the lower limit of detection.
Time frame: Week 48
Decrease of HBsAg levels at week 48 compared to baseline.
Time frame: Week 48
Proportion of patients with HBsAg seroconversion.
Time frame: Week 48
Proportion of patients with HBeAg below the lower limit of detection for patients with baseline HBeAg positive.
Time frame: Week 48
Proportion of patients with HBeAg seroconversion for patients with baseline HBeAg positive.
Time frame: Week 48
Serious adverse events.
Time frame: from baseline to 48 weeks.
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