protocolSection identificationModule nctId: NCT06323681, orgStudyIdInfo id: Leading Study, briefTitle: Pegylated Interferon α in Previously Interferon-treated CHB（Leading Study）, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-04, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Qing XIe, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Hepatitis b, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 2016, type: ESTIMATED, armsInterventionsModule interventions name: Peginterferon α-2b based treatment group, interventions name: NAs monotherapy group, outcomesModule primaryOutcomes measure: Proportion of patients with HBsAg below the lower limit of detection., secondaryOutcomes measure: Decrease of HBV DNA levels at week 48 compared to baseline., secondaryOutcomes measure: Proportion of patients with HBV DNA below the lower limit of detection., secondaryOutcomes measure: Decrease of HBsAg levels at week 48 compared to baseline., secondaryOutcomes measure: Proportion of patients with HBsAg seroconversion., secondaryOutcomes measure: Proportion of patients with HBeAg below the lower limit of detection for patients with baseline HBeAg positive., secondaryOutcomes measure: Proportion of patients with HBeAg seroconversion for patients with baseline HBeAg positive., secondaryOutcomes measure: Serious adverse events., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Qing Xie, MD, PhD., role: CONTACT, phone: 0086-021-64370045, phoneExt: 680403, email: xieqingrjh@163.com, contacts name: Honglian Gui, MD,PhD, role: CONTACT, phone: 0086-021-64370045, phoneExt: 680419, email: lillian_ghl@163.com, contacts name: Qing Xie, MD, PhD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False