[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598449":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":19,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":19,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":19,"overallStatus":48,"whyStopped":19,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":19},{"fullName":5,"class":6},"Shenzhen Third People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Peg-IFN α-2b combined with NAs","EXPERIMENTAL","received Peg-IFN α-2b combined with NAs Adults aged 18-65 years, regardless of gender; HBsAg-positive for ≥6 months; HBeAg-negative; HBsAg quantification ≤1500 IU\u002FmL; No restriction on HBV DNA quantification; ALT \\\u003C10×ULN (upper limit of normal, ≤400 IU\u002FL); No prior interferon therapy within the past 1 year; Signed informed consent form obtained;",[13],"Drug: Peg-IFN α-2b combined with NAs",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Peg-IFN α-2b (1.5 μg\u002Fkg\u002Fweek) combined with NAs",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Qingxian Cai, professor","CONTACT","18127814825","41180423@qq.com",{"type":27,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100598449","phase-4-clinical-efficacy-of-pegylated-interferon-alpha-2b-combined-with-nucleostide-analogues-in-the-treatment-of-chronic-hepatitis-b-patients-100598449",false,"NCT07071636","Clinical Efficacy of Pegylated Interferon Alpha-2b Combined With Nucleos(t)Ide Analogues in the Treatment of Chronic Hepatitis B Patients","A Prospective Study Evaluating Pegylated Interferon Alpha-2b and Nucleos(t)Ide Analogues in Treating Chronic Hepatitis B With or Without Metabolic Dysfunction-Associated Steatotic Liver Disease","Inclusion Criteria: Adults aged 18-65 years, regardless of gender; HBsAg-positive for ≥6 months; HBeAg-negative; HBsAg quantification ≤1500 IU\u002FmL; No restriction on HBV DNA quantification; ALT \\\u003C10×ULN (upper limit of normal, ≤400 IU\u002FL); No prior interferon therapy within the past 1 year; Signed informed consent form obtained; Exclusion of comorbid metabolic dysfunction-associated steatotic liver disease (MASLD).\n\nMASLD meets at least one of the following five metabolic criteria:\n\nBMI ≥23 or waist circumference \\>94 cm (male)\u002F80 cm (female) Fasting plasma glucose ≥5.6 mmol\u002FL or 2-hour postprandial blood glucose ≥7.8 mmol\u002FL or HbA1c ≥5.7% or diagnosis of Type 2 Diabetes Mellitus or undergoing anti-diabetic therapy Blood pressure ≥130\u002F85 mmHg or receiving antihypertensive medication Plasma triglycerides ≥1.70 mmol\u002FL or current lipid-lowering treatment Plasma HDL-C: \\\u003C1.0 mmol\u002FL (male) or \\\u003C1.3 mmol\u002FL (female) or active lipid-modifying therapy -\n\nExclusion Criteria: Patients who are pregnant or breastfeeding. Excessive alcohol consumption: ethanol intake greater than 210g\u002Fweek for males and greater than 120g\u002Fweek for females (according to the \"Guidelines for the Prevention and Treatment of Metabolic Associated (Non-alcoholic) Fatty Liver Disease (2024 Edition)\") Individuals co-infected with HIV. Patients co-infected with HCV virus or other viral hepatitis and other chronic liver diseases.\n\nPatients with liver cirrhosis (compensated or decompensated), liver failure, hepatocellular carcinoma, or any type of malignant tumor.\n\nPatients with serious heart, brain, kidney, and hematopoietic system diseases or oncologic diseases.\n\nPatients with severe psychiatric abnormalities as well as uncontrolled hypertension, diabetes, thyroid dysfunction, etc.\n\nPeripheral blood leukocyte count \\\u003C3.5×10\\^9\u002FL and\u002For platelet count \\\u003C80×10\\^9\u002FL. Patients allergic to interferon, as well as those with contraindications to interferon indicated in the package insert.\n\nPatients deemed unsuitable for enrollment by the researcher.\n\n\\-","ALL","18 Years","65 Years",{"count":39,"type":40},830,"ESTIMATED","INTERVENTIONAL",[43],"PHASE4","Background Chronic hepatitis B (CHB) is a global health issue that affects a large number of patients. There is currently controversy regarding the treatment strategies for CHB patients with metabolic-associated steatoliver disease (MASLD). Therefore, this study aims to conduct a prospective cohort study to compare the therapeutic effects of pegylated interferon α-2b (Peg IFNα-2b) combined with nucleos(t)ide analogues (NAs) in CHB patients with and without MASLD, and to explore the metabolic improvement effects of Peg IFNα-2b treatment in CHB patients with MASLD.\n\nDesign This study is a single-center, non-randomized controlled clinical trial. The subjects are CHB patients planned to receive Peg IFNα-2b combined with NAs, who will be naturally divided into two groups based on the presence or absence of MASLD. The study period is from September 15, 2024, to December 31, 2029, with a planned enrollment of 830 patients.\n\nMethods Inclusion Criteria: Adults aged 18 to 65 years, with HBsAg positivity for more than 6 months, HBeAg negativity, HBsAg level ≤1500 IU\u002Fml, ALT \\\u003C10 ULN (400 IU\u002FL), no interferon treatment in the past year, and signed informed consent.\n\nGrouping Criteria: Patients will be divided into two groups based on the presence or absence of MASLD. MASLD is defined by hepatic steatosis confirmed by imaging or liver biopsy, and the presence of at least one of the following five metabolic factors: BMI ≥23 or waist circumference exceeding the standard, abnormal blood glucose, blood pressure ≥130\u002F85 mmHg, plasma triglycerides ≥1.70 mmol\u002FL, and abnormal plasma high-density lipoprotein cholesterol.\n\nExclusion Criteria: Pregnant or breastfeeding patients, heavy drinkers, patients with HIV infection, co-infected with other viral hepatitis, patients with liver cirrhosis or hepatocellular carcinoma, severe cardiocerebrovascular or renal diseases, psychiatric abnormalities, abnormal peripheral blood leukocytes or platelet count, interferon allergy, etc.\n\nWithdrawal Criteria: Patients who withdraw informed consent, request to exit, experience severe adverse events, have serious protocol violations, become pregnant, have poor compliance, are lost to follow-up, or whose continued participation in the study is deemed unsafe by the investigator.\n\nResearch Endpoints Primary Endpoint: HBsAg clearance rate at 48 weeks of treatment. Secondary Endpoints: Proportion and baseline reduction of HBsAg \\\u003C1500 IU\u002Fml at the end of treatment, reduction of HBV DNA levels from baseline and proportion below the detection limit, clearance and seroconversion rates of HBeAg in HBeAg-positive patients, and the incidence of cardiovascular disease in MASLD patients at the end of treatment.\n\nConclusion This study aims to provide evidence for the individualized treatment of CHB patients with MASLD, clarify the impact of MASLD on the treatment response of CHB patients, optimize treatment protocols, increase clinical cure rates, and explore new strategies for improving patients' metabolic functions. Through this study, we hope to provide more precise decision-making support for clinicians, thereby improving patients' quality of life and long-term prognosis.",[46,47],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Chronic Hepatitis B","NOT_YET_RECRUITING","2025-07-08",{"date":51,"type":52},"2025-07-17","ACTUAL",{"date":54,"type":40},"2025-08-15",{"date":56,"type":40},"2029-09-30",{"name":5,"class":6}]