[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600312":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":38,"locations":44,"responsibleParty":63,"collaborators":27,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":27,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":27,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":88,"whyStopped":27,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Shanghai Zhimeng Biopharma, Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A:ZM-H1505R + NAs","EXPERIMENTAL","ZM-H1505R 100mg,QD + NAs(ETV or TDF or TAF or TMF)",[13,14],"Drug: ZM-H1505R 100mg","Combination Product: NAs （\"Entecavir\"or\"Tenofovir\"or\"Tenofovir alafenamide\"or\"TMF\"） treatments",{"label":16,"type":17,"description":18,"interventionNames":19},"Group B: ZM-H1505R Placebo + NAs","PLACEBO_COMPARATOR","ZM-H1505R Placebo 100mg,QD + NAs(ETV or TDF or TAF or TMF)",[20,14],"Other: ZM-H1505R Placebo",[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","ZM-H1505R 100mg","ZM-H1505R(100mg,QD) will be used in Part A double-blind treatment period for 48 weeks and Part B open-label extension period 144 weeks.",[9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"OTHER","ZM-H1505R Placebo","ZM-H1505R Placebo(100mg,QD) will be used in Part A double-blind treatment period for 48 weeks.",[16],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":27},"COMBINATION_PRODUCT","NAs （\"Entecavir\"or\"Tenofovir\"or\"Tenofovir alafenamide\"or\"TMF\"） treatments","All eligible subjects will be use NAs （\"Entecavir\"or\"Tenofovir\"or\"Tenofovir alafenamide\"or\"TMF\"） treatments during the study for 148 weeks, including Part A and Part B.\n\nSubjects will continue to use the NAs as combination therapy before enrollment, the dosage will not be adjusted during the study. Subjects use in accordance with medical advice andinstructions.",[9,16],[39],{"name":40,"role":41,"phone":42,"phoneExt":27,"email":43},"Project Manager","CONTACT","+8615800984667","adeng@corebiopharma.com",[45],{"facility":46,"status":27,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"The First Hospital of Jilin University","Changchun","Jilin","130000","China","CN",{"type":53,"coordinates":54},"Point",[55,56],125.32278,43.88,{"lat":56,"lon":55},[59],{"name":60,"role":41,"phone":61,"phoneExt":27,"email":62},"Junqi Niu","+8613756661205","junqiniu@aliyun.com",{"type":64,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100600312","phase-3-a-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-zm-h1505r-in-patients-with-chb-100600312",false,"NCT07095855","A Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R in Patients With CHB","A Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Extension Phase III Study to Evaluate the Efficacy and Safety of ZM-H1505R (Canocapavir) in Combination With Nucleos(t)Ide Analog(NAs) Compared With NAs Monotherapy in Patients With Chronic Hepatitis B Who Have Received NAs Monotherapy for at Least 12 Months","Inclusion Criteria:\n\n* 1.Able to understand and sign the written informed consent form;\n* 2.Adult males and females aged 18-65 years(inclusive) at screening;\n* 3.Have been used NAs monotherapy with ETV(0.5 mg or 1.0mg, QD),TDF (300 mg, QD),TAF (25 mg, QD),or TMF (25 mg, OD)for at least 12 months at the time of enrollment; Have been on stable and continuous use of one of these medications for at least 6months, and do not plan to switch to any other NAs class of medications after entering this clinical trial;\n* 4.Evidence of prior HBV infection (e.g., HBsAg and\u002For HBV DNA positive), or HBsAg positive at screening;\n* 5.HBV DNA ≥50 IU\u002FmL as measured by a local healthcare facility within 30 days prior to screening and HBV DNA ≥50 IU\u002FmL as confirmed by central laboratory testing at the time of screening;\n* 6.HBeAg positivity confirmed by central laboratory testing at screening;\n* 7.Women of childbearing potential or males with female partners of childbearing potential must agree to voluntarily use the contraceptive methods specified in the protocol from screening to 28 days after the last dose of the study.\n\nExclusion Criteria:\n\n* 1.Progressive fibrosis or cirrhosis detected at screening, or progressive fibrosis or cirrhosis defined as follows: Metavir ≥ 3 or Ishak fibrosis score ≥ 4 by liver biopsy within 1 year prior to screening; or in the absence of an appropriate liver biopsy, liver stiffness test (FibroScan) ≥ 9 kPa within 3 months prior to screening, or liver stiffness test (FibroTouch) ≥ 9.6 kPa(FibroScan preferred) ;\n* 2.History of hepatocellular carcinoma (HCC); or serum alpha-fetoprotein (AFP) ≥ 50 ng\u002FmL at screening, or imaging examination such as abdominal ultrasound, CT (computed tomography) or MRI (magnetic resonance imaging) suggesting possible HCC;\n* 3.Subjects meeting any of the following clinical laboratory parameters at screening:\n\n  1. Hemoglobin \\\u003C 110 g\u002FL (for males) or \\\u003C 100 g\u002FL (for females);\n  2. Platelet count \\\u003C 90 × 109\u002FL;\n  3. Neutrophil count \\\u003C 1.5 × 109\u002FL;\n  4. Alanine aminotransferase (ALT) or Aspartate aminotransferase(AST)\\> 3 × upper limit of normal (×ULN);\n  5. International normalized ratio (INR) of prothrombin time \\> 1.3;\n  6. Albumin \\\u003C 35 g\u002FL;\n  7. Total bilirubin \\> 2 × ULN, and direct bilirubin \\> 1.5 × ULN;\n  8. Estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m2(calculated using the CKD-MDRD formula).\n* 4.Abnormal result of electrocardiogram (ECG) at screening and inappropriate for the study participation judged by the investigator; or QTcF (QT corrected using the Fridericia formula): \\> 450 ms for males, \\> 470 ms for females at screening;\n* 5.Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV); Note: Subjects with positive HCV antibody (Ab) but negative HCV RNA and subjects with positive HEV immunoglobulin M (IgM) but negative HEV RNA will NOT be excluded.\n* 6.Other malignancy unless the subject's malignancy has been cured by surgical resection (e.g., basal cell skin cancer); Note: Subjects who are suspected of having malignancy must be excluded regardless of evidence of local recurrence or metastasis.\n* 7.History of chronic liver disease with a non-HBV etiology, such as alcoholic liver disease, autoimmune liver disease, hereditary liver disease, non-alcoholic fatty liver disease, except for simple fatty liver disease;\n* 8.Other concurrent severe systemic diseases or clinical manifestations, for which the investigator considers not suitable to participate in this study;\n* 9.Use of any investigational product or drug not approved by regulatory authorities within 3 months prior to screening;\n* 10.History of persistent alcohol consumption (alcohol consumption exceeding 40 g ethanol for males or 20g ethanol for females per day on average) within 6 months prior to screening;\n* 11.History of drug dependence or drug abuse;\n* 12.Pregnant or breastfeeding women;\n* 13.Known hypersensitivity to the active ingredient or formulation excipients of the investigational drug;\n* 14.Inappropriate for the study participation for any reason not otherwise listed as judged by the investigator.","ALL","18 Years","65 Years",{"count":76,"type":77},1300,"ESTIMATED","INTERVENTIONAL",[80],"PHASE3","This study is divided into two parts. Part A is a multicenter, randomized, double-blind, placebo controlled phase Ill clinical trial, designed to evaluate the efficacy and safety of ZM-H1505R in combination with NAs versus NAs monotherapy with HBV DNA ≥ 50 IU\u002FmL and are HBeAg positive who have received NAs monotherapy for at least 12months.Part B is an open-label extension and follow-up period designed to evaluate the long-term safety and efficacy of ZM-H1505R in combination with NAs.",[83],"Chronic Hepatitis B",[85,86,87],"ZM-H1505R","Hepatitis B","CHB","NOT_YET_RECRUITING","2025-07-30",{"date":91,"type":92},"2025-08-03","ACTUAL",{"date":94,"type":77},"2025-08",{"date":96,"type":77},"2030-01",{"name":5,"class":6},1]