[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568362":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":103,"collaborators":20,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":20,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"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",[32,53,67,83],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Massachusetts General Hospital\u002FHarvard University","RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-71.05977,42.35843,{"lat":44,"lon":43},[47,51],{"name":48,"role":28,"phone":49,"phoneExt":20,"email":50},"Raymond T Chung, MD","617-724-75","Chung.Raymond@mgh.harvard.edu",{"name":48,"role":52,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"facility":54,"status":34,"city":55,"state":55,"zip":20,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Queen Mary Hospital, The University of Hong Kong","Hong Kong","HK",{"type":41,"coordinates":58},[59,60],114.17469,22.27832,{"lat":60,"lon":59},[63],{"name":64,"role":28,"phone":65,"phoneExt":20,"email":66},"Man-Fung Yuen, MBBS, MD, PhD, DSc","852-2255 3579","mfyuen@hku.hk",{"facility":68,"status":34,"city":69,"state":20,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"ICS ARENSIA Exploratory Medicine SRL","Chisinau","2025","Moldova","MD",{"type":41,"coordinates":74},[75,76],28.85938,47.00902,{"lat":76,"lon":75},[79],{"name":80,"role":28,"phone":81,"phoneExt":20,"email":82},"Manager, Projects & Research Logistics","373-78883368","alexei.haceatrean@arensia-em.com",{"facility":84,"status":34,"city":85,"state":20,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"New Zealand Clinical Research","Auckland","1010","New Zealand","NZ",{"type":41,"coordinates":90},[91,92],174.76349,-36.84853,{"lat":92,"lon":91},[95,99],{"name":96,"role":28,"phone":97,"phoneExt":20,"email":98},"Edward Gane, MD","64-2-154-8371","EdGane@adhb.govt.nz",{"name":100,"role":28,"phone":101,"phoneExt":20,"email":102},"Sophie Townshend, Study Coordinator","64-9-373-3474","sophie.townshend@nzcr.co.nz",{"type":104,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100568362","phase-1-phase-1-study-to-evaluate-safety-and-antiviral-activity-of-pbgene-hbv-in-adult-patients-with-chronic-hepatitis-b-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":117,"type":118},45,"ESTIMATED","INTERVENTIONAL",[121],"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.",[124],"HEPATITIS B CHRONIC",[124,126,127,17],"Gene Therapy","Gene Editing","2025-09-22",{"date":130,"type":131},"2025-09-26","ACTUAL",{"date":133,"type":131},"2024-11-14",{"date":135,"type":118},"2026-12",{"name":5,"class":6},4]