[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568362":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":45,"studyPopulation":37,"armGroups":46,"interventions":53,"overallOfficials":59,"centralContacts":63,"locations":69,"responsibleParty":203,"collaborators":37,"id":205,"slug":206,"hasResults":207,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":207,"sex":213,"minAge":214,"maxAge":215,"enrollmentInfo":216,"targetDuration":37,"studyType":219,"phases":220,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":72,"whyStopped":37,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},{"fullName":5,"class":6},"Precision BioSciences, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Safety to Assess Treatment-emergent Adverse Events (TEAEs)","Frequency of TEAEs","4 weeks after final dose",[14,18,22,25,28,31,34],{"measure":15,"description":16,"timeFrame":17},"Additional Safety","Frequency and severity of adverse events and changes in physical examinations, vital signs, and safety labs (hematology, chemistry, and urinalysis)","48 weeks",{"measure":19,"description":20,"timeFrame":21},"Pharmacokinetics of AUC","Total PBGENE-HBV exposure over time","4 weeks",{"measure":23,"description":24,"timeFrame":21},"Pharmacokinetics of Cmax","Time at which Cmax (maximum peak concentration of PBGENE-HBV) is observed",{"measure":26,"description":27,"timeFrame":21},"Pharmacokinetics of Cmin","Minimum (or trough) concentration of PBGENE-HBV",{"measure":29,"description":30,"timeFrame":21},"Pharmacokinetics of half life (t1\u002F2)","Terminal half life",{"measure":32,"description":33,"timeFrame":17},"Antiviral Activity of HBsAg and Anti-HBs","Changes from baseline in hepatitis B surface antigen (HBsAg) and anti-HBs levels",{"measure":35,"description":36,"timeFrame":17},"Antiviral Activity of HBV DNA","Changes from baseline of HBV DNA",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":37,"timePerspective":37,"maskingInfo":43},"NA","SEQUENTIAL","Part 1 is to identify a safe and well tolerated dose regimen of PBGENE-HBV Part 2 is an expansion cohort to aid in selecting a dosing regimen.","TREATMENT",{"masking":44,"maskingDescription":37,"whoMasked":37},"NONE","Refer to key Inclusion and Exclusion criteria.",[47],{"label":48,"type":49,"description":50,"interventionNames":51},"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.",[52],"Biological: PBGENE-HBV",[54],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":37},"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.",[48],[60],{"name":61,"affiliation":5,"role":62},"Oby Sogbetun Medical Monitor, MD","STUDY_DIRECTOR",[64],{"name":65,"role":66,"phone":67,"phoneExt":37,"email":68},"Precision Trial Manager","CONTACT","800-371-8953","ELIMINATE-B@precisionbiosciences.com",[70,91,111,126,142,163,184],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Massachusetts General 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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":217,"type":218},45,"ESTIMATED","INTERVENTIONAL",[221],"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.",[224],"HEPATITIS B CHRONIC",[224,226,227,56],"Gene Therapy","Gene Editing","2026-08-21",{"date":230,"type":231},"2026-08-24","ACTUAL",{"date":233,"type":231},"2024-11-14",{"date":235,"type":218},"2027-06",{"name":5,"class":6},7]