protocolSection identificationModule nctId: NCT06368882, orgStudyIdInfo id: Yongping _Chen, briefTitle: Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT）, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Wenzhou Medical University, class: OTHER, descriptionModule briefSummary: This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease.A total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group（500 patients receiving NAs monotherapy） according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly.The primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of treatment, (2) Cumulative HBsAg clearance at week 24、120、144、168、192、216 and 240; (3) The improvement of liver function level(ALT, AST, TBIL, etc.), blood lipid (TC, TG, LDL-C, HDL-C, etc.), fasting blood glucose, insulin resistance index (HOMA-IR), controlled attenuation parameter, body mass index, liver stiffness measurement, liver histological fibrosis, FIB-4 index from baseline; (4)Incidence of liver cirrhosis and hepatocellular carcinoma during follow-up.The security assessment includes adverse events, vital signs, and imaging., conditionsModule conditions: Nonalcoholic Fatty Liver Disease, conditions: Chronic Hepatitis b, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Peg-Interferon α, outcomesModule primaryOutcomes measure: HBsAg clearance, secondaryOutcomes measure: HBsAg clearance at 96 weeks, secondaryOutcomes measure: Cumulative HBsAg clearance rate, secondaryOutcomes measure: Liver Function Tests, secondaryOutcomes measure: The incidence of liver cirrhosis and liver cancer, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ningbo No.2 Hospital, status: RECRUITING, city: Ningbo, country: China, contacts name: Hongshan Li, role: CONTACT, phone: 13738865021, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Ruian People's Hospital, status: RECRUITING, city: Rui'an, country: China, contacts name: Liang Hong, role: CONTACT, phone: 13958805550, locations facility: The Second Affiliated Hospital of Wenzhou Medical University, status: RECRUITING, city: Wenzhou, country: China, contacts name: Chenwei Pan, role: CONTACT, phone: 13587655994, geoPoint lat: 27.99942, lon: 120.66682, locations facility: Wenzhou People's Hospital, status: RECRUITING, city: Wenzhou, country: China, contacts name: Ran Ding, role: CONTACT, phone: 18057788513, geoPoint lat: 27.99942, lon: 120.66682, locations facility: Yueqing People's Hospital, status: RECRUITING, city: Yueqing, country: China, contacts name: Hui Zhao, role: CONTACT, phone: 13968713322, hasResults: False