Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-03-13 @ 1:57 PM
Study NCT ID:
NCT06680232
Status:
RECRUITING
Last Update Posted:
2025-09-26
First Post:
2024-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2024-10-24', 'studyFirstSubmitQcDate': '2024-11-06', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety to Assess Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': '4 weeks after final dose', 'description': 'Frequency of TEAEs'}], 'secondaryOutcomes': [{'measure': 'Additional Safety', 'timeFrame': '48 weeks', 'description': 'Frequency and severity of adverse events and changes in physical examinations, vital signs, and safety labs (hematology, chemistry, and urinalysis)'}, {'measure': 'Pharmacokinetics of AUC', 'timeFrame': '4 weeks', 'description': 'Total PBGENE-HBV exposure over time'}, {'measure': 'Pharmacokinetics of Cmax', 'timeFrame': '4 weeks', 'description': 'Time at which Cmax (maximum peak concentration of PBGENE-HBV) is observed'}, {'measure': 'Pharmacokinetics of Cmin', 'timeFrame': '4 weeks', 'description': 'Minimum (or trough) concentration of PBGENE-HBV'}, {'measure': 'Pharmacokinetics of half life (t1/2)', 'timeFrame': '4 weeks', 'description': 'Terminal half life'}, {'measure': 'Antiviral Activity of HBsAg and Anti-HBs', 'timeFrame': '48 weeks', 'description': 'Changes from baseline in hepatitis B surface antigen (HBsAg) and anti-HBs levels'}, {'measure': 'Antiviral Activity of HBV DNA', 'timeFrame': '48 weeks', 'description': 'Changes from baseline of HBV DNA'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HEPATITIS B CHRONIC', 'Gene Therapy', 'Gene Editing', 'PBGENE-HBV'], 'conditions': ['HEPATITIS B CHRONIC']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Refer to key Inclusion and Exclusion criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT06680232', 'acronym': 'ELIMINATE-B', 'briefTitle': 'Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Precision BioSciences, Inc.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'PBGENE-HBV-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV.', 'description': '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.', 'interventionNames': ['Biological: PBGENE-HBV']}], 'interventions': [{'name': 'PBGENE-HBV', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raymond T Chung, MD', 'role': 'CONTACT', 'email': 'Chung.Raymond@mgh.harvard.edu', 'phone': '617-724-75'}, {'name': 'Raymond T Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital/Harvard University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Hong Kong', 'state': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Man-Fung Yuen, MBBS, MD, PhD, DSc', 'role': 'CONTACT', 'email': 'mfyuen@hku.hk', 'phone': '852-2255 3579'}], 'facility': 'Queen Mary Hospital, The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '2025', 'city': 'Chisinau', 'status': 'RECRUITING', 'country': 'Moldova', 'contacts': [{'name': 'Manager, Projects & Research Logistics', 'role': 'CONTACT', 'email': 'alexei.haceatrean@arensia-em.com', 'phone': '373-78883368'}], 'facility': 'ICS ARENSIA Exploratory Medicine SRL', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '1010', 'city': 'Auckland', 'status': 'RECRUITING', 'country': 'New Zealand', 'contacts': [{'name': 'Edward Gane, MD', 'role': 'CONTACT', 'email': 'EdGane@adhb.govt.nz', 'phone': '64-2-154-8371'}, {'name': 'Sophie Townshend, Study Coordinator', 'role': 'CONTACT', 'email': 'sophie.townshend@nzcr.co.nz', 'phone': '64-9-373-3474'}], 'facility': 'New Zealand Clinical Research', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}], 'centralContacts': [{'name': 'Precision Trial Manager', 'role': 'CONTACT', 'email': 'ELIMINATE-B@precisionbiosciences.com', 'phone': '800-371-8953'}], 'overallOfficials': [{'name': 'Stanley Frankel, MD Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Precision BioSciences, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Precision BioSciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}