Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-01-02 @ 11:17 AM
Study NCT ID:
NCT04749368
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2021-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006505', 'term': 'Hepatitis'}], 'ancestors': [{'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': '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'dispFirstSubmitDate': '2024-06-13', 'completionDateStruct': {'date': '2023-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-16', 'studyFirstSubmitDate': '2021-02-07', 'studyFirstSubmitQcDate': '2021-02-07', 'dispFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with sustained HBsAg loss during the 48-week follow-up period after NrtI withdrawal', 'timeFrame': 'up to Week 96'}, {'measure': 'Number of participants with Adverse Events (AE)', 'timeFrame': 'up to Week 96'}, {'measure': 'Number of participants with Serious Adverse Events (SAE)', 'timeFrame': 'up to Week 96'}, {'measure': 'Number of participants with abnormalities in clinical laboratory tests', 'timeFrame': 'up to Week 96'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis B Virus', 'Chronic Hepatitis B', 'HBV', 'Hepatitis'], 'conditions': ['Hepatitis B, Chronic']}, 'referencesModule': {'references': [{'pmid': '40043858', 'type': 'DERIVED', 'citation': 'Ji Y, Le Bert N, Lai-Hung Wong G, Douglas MW, Lee A, Zhu C, Wang B, Lv J, Li D, Tan Y, Ma H, Chen J, Chen X, Zhu Q, Yuen MF, Bertoletti A. The Impact of Hepatitis B Surface Antigen Reduction via Small Interfering RNA Treatment on Natural and Vaccine (BRII-179)-Induced Hepatitis B Virus-Specific Humoral and Cellular Immune Responses. Gastroenterology. 2025 Jul;169(1):136-149. doi: 10.1053/j.gastro.2025.02.016. Epub 2025 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 - 60\n* Body mass index ≥ 18 kg/m\\^2 and ≤ 32 kg/m\\^2\n* Chronic HBV infection as defined by a positive serum HBsAg for ≥ 6 months\n\nExclusion Criteria:\n\n* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation\n* Significant fibrosis or cirrhosis\n* History or evidence of drug or alcohol abuse\n* History of intolerance to SC or IM injection\n* History of chronic liver disease from any cause other than chronic HBV infection\n* History of hepatic decompensation'}, 'identificationModule': {'nctId': 'NCT04749368', 'briefTitle': 'Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Brii Biosciences Limited'}, 'officialTitle': 'A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection', 'orgStudyIdInfo': {'id': 'BRII-179-835-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A', 'description': 'Participants will receive BRII-835 (VIR-2218) for 32 weeks', 'interventionNames': ['Drug: BRII-835 (VIR-2218)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B', 'description': 'Participants will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with IFN-α up to Week 40', 'interventionNames': ['Drug: BRII-835 (VIR-2218)', 'Biological: BRII-179 (VBI-2601) with IFN-α']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C', 'description': 'Participant will receive BRII-835 (VIR-2218) and BRII-179 (VBI-2601) up to Week 40', 'interventionNames': ['Drug: BRII-835 (VIR-2218)', 'Biological: BRII-179 (VBI-2601)']}], 'interventions': [{'name': 'BRII-835 (VIR-2218)', 'type': 'DRUG', 'description': 'BRII-835 (VIR-2218) will be given by subcutaneous injection', 'armGroupLabels': ['Cohort A', 'Cohort B', 'Cohort C']}, {'name': 'BRII-179 (VBI-2601) with IFN-α', 'type': 'BIOLOGICAL', 'description': 'BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection', 'armGroupLabels': ['Cohort B']}, {'name': 'BRII-179 (VBI-2601)', 'type': 'BIOLOGICAL', 'description': 'BRII-179 (VBI-2601) will be administered by intramuscular injection', 'armGroupLabels': ['Cohort C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2747', 'city': 'Kingswood', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigative Site 61002', 'geoPoint': {'lat': -33.75614, 'lon': 150.72346}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Investigative Site 61001', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Investigative Site 61004', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '500', 'city': 'Changhua, Taiwan', 'country': 'China', 'facility': 'Investigative Site 88602'}, {'city': 'Hong Kong', 'country': 'China', 'facility': 'Investigative Site 85201', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'China', 'facility': 'Investigative Site 85202', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'China', 'facility': 'Investigative Site 85203', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '83301', 'city': 'Kaohsiung, Taiwan', 'country': 'China', 'facility': 'Investigative Site 88601', 'geoPoint': {'lat': 32.32812, 'lon': 118.76384}}, {'city': 'Kaohsiung, Taiwan', 'country': 'China', 'facility': 'Investigative Site 88604', 'geoPoint': {'lat': 32.32812, 'lon': 118.76384}}, {'city': 'NEW Territories, Hong Kong', 'country': 'China', 'facility': 'Investigative Site 85204'}, {'zip': '40447', 'city': 'Taichung, Taiwan', 'country': 'China', 'facility': 'Investigative Site 88603', 'geoPoint': {'lat': 32.32812, 'lon': 118.76384}}, {'zip': '10048', 'city': 'Taipei CITY', 'country': 'China', 'facility': 'Investigative Site 88605'}, {'zip': '9016', 'city': 'Dunedin Central', 'state': 'Dunedin', 'country': 'New Zealand', 'facility': 'Investigative Site 64002'}, {'zip': '2025', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Investigative Site 64001', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Investigative Site 65001', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Investigative Site 65002', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Investigative Site 82004', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '13496', 'city': 'Seongnam-si, Gyeonggi-do', 'country': 'South Korea', 'facility': 'Investigative Site 82003'}, {'zip': '3080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Investigative Site 82001', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '3722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Investigative Site 82005', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '5505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Investigative Site 82002', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Investigative Site 66001', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Investigative Site 66003', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '40002', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Investigative Site 66002', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '11000', 'city': 'Nonthaburi', 'country': 'Thailand', 'facility': 'Investigative Site 66005', 'geoPoint': {'lat': 13.86075, 'lon': 100.51477}}, {'zip': '11000', 'city': 'Nonthaburi', 'country': 'Thailand', 'facility': 'Investigative Site 66006', 'geoPoint': {'lat': 13.86075, 'lon': 100.51477}}, {'zip': '12120', 'city': 'Pathum Thani', 'country': 'Thailand', 'facility': 'Investigative Site 66004', 'geoPoint': {'lat': 14.01346, 'lon': 100.53049}}, {'zip': '90110', 'city': 'Songkhla', 'country': 'Thailand', 'facility': 'Investigative Site 66007', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}], 'overallOfficials': [{'name': 'Xiaofei Chen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Brii Biosciences Limited'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brii Biosciences Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Vir Biotechnology, Inc.', 'class': 'INDUSTRY'}, {'name': 'VBI Vaccines Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}