[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568362":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":99,"collaborators":20,"id":101,"slug":20,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":20,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Precision BioSciences, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV.","EXPERIMENTAL","All participants will receive a finite course of multiple IV dose administrations of PBGENE-HBV. In Part 1, this will be done in a dose escalation manner which may be evaluated further in a Part 2 expansion cohort.",[13],"Biological: PBGENE-HBV",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","PBGENE-HBV","PBGENE-HBV is an in vivo gene editing intervention based on a novel proprietary ARCUS® platform designed to potentially cure chronic hepatitis B virus (HBV) by eliminating cccDNA, the key source of replicating hepatitis B virus, while also inactivating integrated HBV DNA in hepatocytes.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Stanley Frankel, MD Medical Monitor","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Precision Trial Manager","CONTACT","800-371-8953","ELIMINATE-B@precisionbiosciences.com",[32,52,65,80],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Massachusetts General Hospital\u002FHarvard University","RECRUITING","Boston","Massachusetts","02114","United States",{"type":40,"coordinates":41},"Point",[42,43],-71.05977,42.35843,{"lat":43,"lon":42},[46,50],{"name":47,"role":28,"phone":48,"phoneExt":20,"email":49},"Raymond T Chung, MD","617-724-75","Chung.Raymond@mgh.harvard.edu",{"name":47,"role":51,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":53,"status":34,"city":54,"state":54,"zip":20,"country":54,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Queen Mary Hospital, The University of Hong Kong","Hong Kong",{"type":40,"coordinates":56},[57,58],114.17469,22.27832,{"lat":58,"lon":57},[61],{"name":62,"role":28,"phone":63,"phoneExt":20,"email":64},"Man-Fung Yuen, MBBS, MD, PhD, DSc","852-2255 3579","mfyuen@hku.hk",{"facility":66,"status":34,"city":67,"state":20,"zip":68,"country":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"ICS ARENSIA Exploratory Medicine SRL","Chisinau","2025","Moldova",{"type":40,"coordinates":71},[72,73],28.85938,47.00902,{"lat":73,"lon":72},[76],{"name":77,"role":28,"phone":78,"phoneExt":20,"email":79},"Manager, Projects & Research Logistics","373-78883368","alexei.haceatrean@arensia-em.com",{"facility":81,"status":34,"city":82,"state":20,"zip":83,"country":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"New Zealand Clinical Research","Auckland","1010","New Zealand",{"type":40,"coordinates":86},[87,88],174.76349,-36.84853,{"lat":88,"lon":87},[91,95],{"name":92,"role":28,"phone":93,"phoneExt":20,"email":94},"Edward Gane, MD","64-2-154-8371","EdGane@adhb.govt.nz",{"name":96,"role":28,"phone":97,"phoneExt":20,"email":98},"Sophie Townshend, Study Coordinator","64-9-373-3474","sophie.townshend@nzcr.co.nz",{"type":100,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100568362",false,"NCT06680232","Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B","A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants With Chronic Hepatitis B (ELIMINATE-B)","ELIMINATE-B","Key Inclusion Criteria:\n\n* Male or women of non-child bearing potential\n* BMI 18.0 to 35.0\n* Good overall health deemed by the study Investigator\n* CHB infection documented at least 12 months prior to screening\n* HBeAg-negative CHB\n* Must be virologically suppressed on current NA treatment\n\nKey Exclusion Criteria:\n\n* No history of cirrhosis of the liver\n* No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.\n* No signs of hepatocellular carcinoma\n* Not received an organ transplant\n* No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)\n* No investigational agent received within 6 months of screening","ALL","18 Years","70 Years",{"count":112,"type":113},45,"ESTIMATED","INTERVENTIONAL",[116],"PHASE1","This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.",[119],"HEPATITIS B CHRONIC",[119,121,122,17],"Gene Therapy","Gene Editing","2025-09-22",{"date":125,"type":126},"2025-09-26","ACTUAL",{"date":128,"type":126},"2024-11-14",{"date":130,"type":113},"2026-12",{"name":5,"class":6},4]