[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631351":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":37,"locations":43,"responsibleParty":58,"collaborators":30,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":30,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":30,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":46,"whyStopped":30,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Huahui Health","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Libevitug 20 mg\u002Fkg","EXPERIMENTAL","Participants will receive libevitug at a dose of 20 mg\u002Fkg Q2W via intravenous infusion for 96 weeks",[13],"Drug: Libevitug 20 mg\u002Fkg",{"label":15,"type":10,"description":16,"interventionNames":17},"Libevitug 10 mg\u002Fkg","Participants will receive libevitug at a dose of 10 mg\u002Fkg Q2W via intravenous infusion for 96 weeks",[18],"Drug: Libevitug 10 mg\u002Fkg",{"label":20,"type":21,"description":22,"interventionNames":23},"Control group\u002Fdelayed treatment with libevitug 20 mg\u002Fkg","ACTIVE_COMPARATOR","Participants will be observed as comparator for 48 weeks, then to receive libevitug 20 mg\u002Fkg for 48 weeks",[24],"Other: Delayed treatment with libevitug",[26,31,33],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Route of administration: intravenous infusion",[9],null,{"type":27,"name":15,"description":28,"armGroupLabels":32,"otherNames":30},[15],{"type":34,"name":35,"description":28,"armGroupLabels":36,"otherNames":30},"OTHER","Delayed treatment with libevitug",[20],[38],{"name":39,"role":40,"phone":41,"phoneExt":30,"email":42},"Jiaying Wen PM","CONTACT","+86 13552466248","wenjiaying@hhhbio.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":30},"The First Hospital of Jilin University","RECRUITING","Changchun","Jilin","130033","China","CN",{"type":53,"coordinates":54},"Point",[55,56],125.32278,43.88,{"lat":56,"lon":55},{"type":59,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100631351","phase-3-a-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-libevitug-in-participants-with-chronic-hdv-infection-d-clear-study-100631351",false,"NCT07499544","A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)","A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Assess Efficacy and Safety of Libevitug Injection in Participants With Chronic Hepatitis Delta Virus Infection (D-clear Study)","Inclusion Criteria:\n\n* Willing to sign written informed consent;\n* Chronic HDV history with at least 6 months;\n* HDV RNA ≥500 IU\u002FmL at screening;\n* ALT \\>1ULN and \\\u003C10×ULN;\n* Able to communicate well and comply with protocol.\n\nExclusion Criteria:\n\n* Concomitant decompensated cirrhosis;\n* Previous or current HCC or suspicion for HCC;\n* Participants with history of alcoholic liver disease, nonalcoholic steatohepatitis or other clinically significant chronic liver diseases not caused by HDV\u002FHBV;\n* Participants with active hepatitis C infection, or HIV infection;\n* Alcohol abuse or drug addiction within 1 year;\n* Participants have participated in other clinical trial within 1 month;\n* Pregnant, lactating women.","ALL","12 Years","70 Years",{"count":71,"type":72},160,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","This is an international, multicenter, randomized, controlled, open-label Phase III trial. It will evaluate the efficacy and safety of libevitug in participants with chronic HDV infection.",[78],"Chronic Hepatitis D Infection",[80,81],"Hepatitis Delta Virus (HDV)","Viral hepatitis","2026-06-08",{"date":84,"type":85},"2026-06-10","ACTUAL",{"date":87,"type":85},"2026-04-22",{"date":89,"type":72},"2030-01-29",{"name":5,"class":6},1]