Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT04507269
Status:
COMPLETED
Last Update Posted:
2024-08-26
First Post:
2020-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@briibio.com', 'phone': '86 10 6299 8808', 'title': 'Clinical Research', 'organization': 'Brii Biosciences Limited'}, 'certainAgreement': {'otherDetails': 'Investigator will submit the proposed publication to sponsor at least 60 days prior to submission to a publisher.\n\nSponsor shall advise investigator any information that are confidential or may impair the availability of patent protection for study inventions.\n\nSponsor may require to remove confidential information and/or to delay the proposed publication or presentation for an additional 60 days to seek patent protection for study inventions.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 48 weeks after the first dose of VIR-2218 or placebo', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1: VIR-2218 100 mg 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1: Placebo', 'description': 'HBeAg negative, participants received 2 SC doses of placebo administered every 4 weeks apart', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 2: Placebo', 'description': 'HBeAg positive, participants received 2 SC doses of placebo administered every 4 weeks apart', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 1: Placebo', 'description': 'HBeAg negative, participants received 2 SC doses of placebo administered every 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'OG004', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'OG005', 'title': 'Part 2: Placebo', 'description': 'HBeAg positive, participants received 2 SC doses of placebo administered every 4 weeks apart'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Any TEAEs of CTCAE Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Any TEAEs of CTCAE Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any TEAEs of CTCAE Grade 3 or above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any drug related TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 48 weeks', 'description': 'Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 are summarized by cohort. Incidence is defined as the number of participants with TEAEs in relation to the total number of participants in the cohort. TEAEs are defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug'}, {'type': 'PRIMARY', 'title': 'Clinical Assessments Including But Not Limited to Laboratory Test Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 1: Placebo', 'description': 'HBeAg negative, participants received 2 SC doses of placebo administered every 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'OG004', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'OG005', 'title': 'Part 2: Placebo', 'description': 'HBeAg positive, participants received 2 SC doses of placebo administered every 4 weeks apart'}], 'classes': [{'title': 'Any post baseline laboratory abnormalities of CTCAE Grade 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Any post baseline laboratory abnormalities of CTCAE Grade 2 or above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any clinically significant vital signs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Any clinically significant ECGs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 48 weeks', 'description': 'Number of participants with graded hematology, coagulation, chemistry abnormalities, and clinically significant abnormalities in vital signs and ECGs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'PK: Maximum Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}], 'classes': [{'title': 'VIR-2218 Cmax (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '120', 'spread': '40.5', 'groupId': 'OG000'}, {'value': '144', 'spread': '100.5', 'groupId': 'OG001'}, {'value': '65.8', 'spread': '58.6', 'groupId': 'OG002'}, {'value': '260', 'spread': '90.4', 'groupId': 'OG003'}]}]}, {'title': 'VIR-2218 Cmax (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '125', 'spread': '48.8', 'groupId': 'OG000'}, {'value': '198', 'spread': '52.9', 'groupId': 'OG001'}, {'value': '76.5', 'spread': '35.7', 'groupId': 'OG002'}, {'value': '268', 'spread': '43.0', 'groupId': 'OG003'}]}]}, {'title': "AS(N-1)3'VIR-2218 Cmax (Day 1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.2', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG000'}, {'value': '31.4', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG001'}, {'value': '28.1', 'spread': '171.1', 'groupId': 'OG003'}]}]}, {'title': "AS(N-1)3'VIR-2218 Cmax (Day 29)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG000'}, {'value': '23.6', 'spread': '48.8', 'groupId': 'OG001'}, {'value': '9.75', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '19.3', 'spread': '82.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Maximum plasma concentrations were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite maximum plasma concentrations (ng/mL)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter'}, {'type': 'SECONDARY', 'title': 'PK: Time to Reach Maximum Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}], 'classes': [{'title': 'VIR-2218 Tmax (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.99', 'groupId': 'OG000', 'lowerLimit': '1.88', 'upperLimit': '8.03'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '0.967', 'upperLimit': '8.08'}, {'value': '4.02', 'groupId': 'OG002', 'lowerLimit': '4.00', 'upperLimit': '7.80'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '4.00', 'upperLimit': '7.58'}]}]}, {'title': 'VIR-2218 Tmax (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.76', 'groupId': 'OG000', 'lowerLimit': '1.08', 'upperLimit': '8.13'}, {'value': '4.02', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '7.85'}, {'value': '2.50', 'groupId': 'OG002', 'lowerLimit': '0.967', 'upperLimit': '4.00'}, {'value': '5.93', 'groupId': 'OG003', 'lowerLimit': '1.00', 'upperLimit': '8.02'}]}]}, {'title': "AS(N-1)3'VIR-2218 Tmax (Day 1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.95', 'groupId': 'OG000', 'lowerLimit': '3.98', 'upperLimit': '8.05'}, {'value': '4.98', 'groupId': 'OG001', 'lowerLimit': '2.03', 'upperLimit': '7.92'}, {'value': '7.80', 'groupId': 'OG002', 'lowerLimit': '7.80', 'upperLimit': '7.80'}, {'value': '5.79', 'groupId': 'OG003', 'lowerLimit': '4.00', 'upperLimit': '22.1'}]}]}, {'title': "AS(N-1)3'VIR-2218 Tmax (Day 29)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.76', 'groupId': 'OG000', 'lowerLimit': '4.05', 'upperLimit': '8.13'}, {'value': '5.93', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '8.03'}, {'value': '4.00', 'groupId': 'OG002', 'lowerLimit': '4.00', 'upperLimit': '4.00'}, {'value': '5.93', 'groupId': 'OG003', 'lowerLimit': '4.00', 'upperLimit': '8.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time to Cmax were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite time to Cmax (h)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter'}, {'type': 'SECONDARY', 'title': 'PK: Area Under the Plasma Concentration Versus Time Curve to Last Measurable Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}], 'classes': [{'title': 'VIR-2218 AUClast (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1080', 'spread': '25.3', 'groupId': 'OG000'}, {'value': '1400', 'spread': '115.6', 'groupId': 'OG001'}, {'value': '626', 'spread': '31.1', 'groupId': 'OG002'}, {'value': '3190', 'spread': '42.3', 'groupId': 'OG003'}]}]}, {'title': 'VIR-2218 AUClast (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '854', 'spread': '34.2', 'groupId': 'OG000'}, {'value': '2390', 'spread': '26.6', 'groupId': 'OG001'}, {'value': '580', 'spread': '56.9', 'groupId': 'OG002'}, {'value': '3140', 'spread': '15.8', 'groupId': 'OG003'}]}]}, {'title': "AS(N-1)3'VIR-2218 AUClast (Day 1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '58.7', 'spread': '28.9', 'groupId': 'OG000'}, {'value': '159', 'spread': '30.5', 'groupId': 'OG001'}, {'value': '67.6', 'spread': '2.1', 'groupId': 'OG002'}, {'value': '180', 'spread': '63.4', 'groupId': 'OG003'}]}]}, {'title': "AS(N-1)3'VIR-2218 AUClast (Day 29)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50.2', 'spread': '52.5', 'groupId': 'OG000'}, {'value': '140', 'spread': '81.2', 'groupId': 'OG001'}, {'value': '63.1', 'spread': '6.1', 'groupId': 'OG002'}, {'value': '155', 'spread': '39.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite area under the curve from time 0 to last measurable time (ng\\*h/mL)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter'}, {'type': 'SECONDARY', 'title': 'PK: Area Under the Plasma Concentration Versus Time Curve to Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}], 'classes': [{'title': 'VIR-2218 AUCinf (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2820', 'spread': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'VIR-2218 AUCinf (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2570', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG001'}, {'value': '1210', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG002'}, {'value': '3530', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG003'}]}]}, {'title': "AS(N-1)3'VIR-2218 AUCinf (Day 1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': "AS(N-1)3'VIR-2218 AUCinf (Day 29)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite area under the curve from time 0 to infinity (ng\\*h/mL)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter'}, {'type': 'SECONDARY', 'title': 'PK: Percent of Area Extrapolated From AUC Last to Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}], 'classes': [{'title': 'VIR-2218 %AUCextrap (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.69', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'VIR-2218 %AUCextrap (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '46.2', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG000'}, {'value': '13.8', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG001'}, {'value': '23.9', 'spread': '263.4', 'groupId': 'OG002'}, {'value': '5.88', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG003'}]}]}, {'title': "AS(N-1)3'VIR-2218 %AUCextrap (Day 1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': "AS(N-1)3'VIR-2218 %AUCextrap (Day 29)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '49.2', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Percent of area extrapolated from AUC last to infinity were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite percent of area extrapolated from AUC last to infinity (%)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.', 'unitOfMeasure': '% of AUCinf', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter'}, {'type': 'SECONDARY', 'title': 'PK: Apparent Terminal Elimination Half-life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}], 'classes': [{'title': 'VIR-2218 t1/2 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.16', 'groupId': 'OG001', 'lowerLimit': '4.10', 'upperLimit': '4.22'}]}]}, {'title': 'VIR-2218 t1/2 (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.66', 'groupId': 'OG001', 'lowerLimit': '7.66', 'upperLimit': '7.66'}, {'value': '6.53', 'groupId': 'OG002', 'lowerLimit': '6.53', 'upperLimit': '6.53'}, {'value': '5.49', 'groupId': 'OG003', 'lowerLimit': '5.49', 'upperLimit': '5.49'}]}]}, {'title': "AS(N-1)3'VIR-2218 t1/2 (Day 1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': "AS(N-1)3'VIR-2218 t1/2 (Day 29)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Apparent terminal elimination half-life were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite apparent terminal elimination half-life (h)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter'}, {'type': 'SECONDARY', 'title': 'PK: Apparent Plasma Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}], 'classes': [{'title': 'VIR-2218 CL/F (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35400', 'spread': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'VIR-2218 CL/F (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '39000', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG001'}, {'value': '41300', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG002'}, {'value': '28300', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG003'}]}]}, {'title': "AS(N-1)3'VIR-2218 CL/F (Day 1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': "AS(N-1)3'VIR-2218 CL/F (Day 29)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Apparent plasma clearance were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite apparent plasma clearance CL/F (mL/h)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.', 'unitOfMeasure': 'mL/h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter'}, {'type': 'SECONDARY', 'title': 'PK: Apparent Volume of Distribution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}], 'classes': [{'title': 'VIR-2218 Vz/F (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '213000', 'spread': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'VIR-2218 Vz/F (Day 29)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '431000', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG001'}, {'value': '389000', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG002'}, {'value': '224000', 'spread': 'NA', 'comment': '%Geometric CoV not reported; measurable in 1/4 participants', 'groupId': 'OG003'}]}]}, {'title': "AS(N-1)3'VIR-2218 Vz/F (Day 1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': "AS(N-1)3'VIR-2218 Vz/F (Day 29)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Apparent volume of distribution were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite apparent volume of distribution Vz/F (mL)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.', 'unitOfMeasure': 'mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of VIR-2218 and had 1 post-baseline PK parameter'}, {'type': 'SECONDARY', 'title': 'Maximum Change of Serum HBsAg From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 1: Placebo', 'description': 'HBeAg negative, participants received 2 SC doses of placebo administered every 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'OG004', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'OG005', 'title': 'Part 2: Placebo', 'description': 'HBeAg positive, participants received 2 SC doses of placebo administered every 4 weeks apart'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.064', 'spread': '0.1047', 'groupId': 'OG000'}, {'value': '-1.346', 'spread': '0.5169', 'groupId': 'OG001'}, {'value': '-0.049', 'spread': '0.0158', 'groupId': 'OG002'}, {'value': '-0.793', 'spread': '0.1017', 'groupId': 'OG003'}, {'value': '-1.268', 'spread': '0.1693', 'groupId': 'OG004'}, {'value': '-0.120', 'spread': '0.0826', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 16 weeks', 'description': 'Maximum change of serum HBsAg from Day 1 until 12 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline)', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 non-missing data for antiviral parameters'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serum HBsAg Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 1: Placebo', 'description': 'HBeAg negative, participants received 2 SC doses of placebo administered every 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'OG004', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'OG005', 'title': 'Part 2: Placebo', 'description': 'HBeAg positive, participants received 2 SC doses of placebo administered every 4 weeks apart'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 48 weeks', 'description': 'Number of participants with serum HBsAg \\< 0.05 IU/mL at two or more consecutive measurements', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 non-missing data for antiviral parameters'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Sustained Serum HBsAg Loss for at Least 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 1: Placebo', 'description': 'HBeAg negative, participants received 2 SC doses of placebo administered every 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'OG004', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'OG005', 'title': 'Part 2: Placebo', 'description': 'HBeAg positive, participants received 2 SC doses of placebo administered every 4 weeks apart'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 48 weeks', 'description': 'Number of participants with sustained serum HBsAg \\< 0.05 IU/mL at all visits for at least 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 non-missing data for antiviral parameters'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-HBs Seroconversion at Any Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 1: Placebo', 'description': 'HBeAg negative, participants received 2 SC doses of placebo administered every 4 weeks apart'}, {'id': 'OG003', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'OG004', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'OG005', 'title': 'Part 2: Placebo', 'description': 'HBeAg positive, participants received 2 SC doses of placebo administered every 4 weeks apart'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 48 weeks', 'description': 'Anti-HBs seroconversion is defined as anti-HBs positivity at two or more consecutive measurements', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had at least 1 non-missing data for antiviral activity parameter'}, {'type': 'SECONDARY', 'title': 'For HBeAg-positive Subjects: Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'OG001', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'OG002', 'title': 'Part 2: Placebo', 'description': 'HBeAg positive, participants received 2 SC doses of placebo administered every 4 weeks apart'}], 'classes': [{'title': 'HBeAg loss', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Anti-HBe seroconversion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 48 weeks', 'description': 'HBeAg loss is defined as quantitative HBeAg \\< 0.14 IU/mL at two or more consecutive measurements. Anti-HBe seroconversion is defined as anti-HBe positivity at two or more consecutive measurements.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part 2 (HBeAg positive) participants only; all randomized participants who received at least 1 dose of study drug and had at least 1 non-missing data for antiviral activity parameter'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'FG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}, {'id': 'FG002', 'title': 'Part 1: Placebo', 'description': 'HBeAg negative, participants received 2 SC doses of placebo administered 4 weeks apart'}, {'id': 'FG003', 'title': 'Part 2: VIR-2218 50mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered 4 weeks apart'}, {'id': 'FG004', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered 4 weeks apart'}, {'id': 'FG005', 'title': 'Part 2: Placebo', 'description': 'HBeAg positive, participants received 2 SC doses of placebo administered 4 weeks apart'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Dosed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: VIR-2218 50 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'BG001', 'title': 'Part 1: VIR-2218 100 mg', 'description': 'HBeAg negative, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'BG002', 'title': 'Part 1: Placebo', 'description': 'HBeAg negative, participants received 2 SC doses of placebo administered every 4 weeks apart'}, {'id': 'BG003', 'title': 'Part 2: VIR-2218 50 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 50 mg administered every 4 weeks apart'}, {'id': 'BG004', 'title': 'Part 2: VIR-2218 100 mg', 'description': 'HBeAg positive, participants received 2 SC doses of VIR-2218 100 mg administered every 4 weeks apart'}, {'id': 'BG005', 'title': 'Part 2: Placebo', 'description': 'HBeAg positive, participants received 2 SC doses of placebo administered every 4 weeks apart'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'spread': '9.68', 'groupId': 'BG000'}, {'value': '36.5', 'spread': '9.26', 'groupId': 'BG001'}, {'value': '31.0', 'spread': '5.20', 'groupId': 'BG002'}, {'value': '41.8', 'spread': '4.27', 'groupId': 'BG003'}, {'value': '39.5', 'spread': '10.66', 'groupId': 'BG004'}, {'value': '38.0', 'spread': '11.31', 'groupId': 'BG005'}, {'value': '39.7', 'spread': '9.26', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline log10 hepatitis B surface antigen', 'classes': [{'categories': [{'measurements': [{'value': '2.815', 'spread': '0.4865', 'groupId': 'BG000'}, {'value': '3.278', 'spread': '0.7910', 'groupId': 'BG001'}, {'value': '2.948', 'spread': '0.4822', 'groupId': 'BG002'}, {'value': '3.598', 'spread': '0.5479', 'groupId': 'BG003'}, {'value': '3.243', 'spread': '0.4848', 'groupId': 'BG004'}, {'value': '3.722', 'spread': '0.0729', 'groupId': 'BG005'}, {'value': '3.239', 'spread': '0.5756', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-23', 'size': 1415002, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-02T22:00', 'hasProtocol': True}, {'date': '2021-11-19', 'size': 1225442, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-02T21:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'dispFirstSubmitDate': '2022-07-26', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2020-08-07', 'resultsFirstSubmitDate': '2024-07-02', 'studyFirstSubmitQcDate': '2020-08-07', 'dispFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-01', 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'up to 48 weeks', 'description': 'Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 are summarized by cohort. Incidence is defined as the number of participants with TEAEs in relation to the total number of participants in the cohort. TEAEs are defined as any AEs with an onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.'}, {'measure': 'Clinical Assessments Including But Not Limited to Laboratory Test Results', 'timeFrame': 'up to 48 weeks', 'description': 'Number of participants with graded hematology, coagulation, chemistry abnormalities, and clinically significant abnormalities in vital signs and ECGs'}], 'secondaryOutcomes': [{'measure': 'PK: Maximum Plasma Concentration', 'timeFrame': 'Maximum plasma concentrations were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite maximum plasma concentrations (ng/mL)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.'}, {'measure': 'PK: Time to Reach Maximum Plasma Concentration', 'timeFrame': 'Time to Cmax were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite time to Cmax (h)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.'}, {'measure': 'PK: Area Under the Plasma Concentration Versus Time Curve to Last Measurable Timepoint', 'timeFrame': 'Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite area under the curve from time 0 to last measurable time (ng\\*h/mL)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.'}, {'measure': 'PK: Area Under the Plasma Concentration Versus Time Curve to Infinity', 'timeFrame': 'Area under the curve were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite area under the curve from time 0 to infinity (ng\\*h/mL)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.'}, {'measure': 'PK: Percent of Area Extrapolated From AUC Last to Infinity', 'timeFrame': 'Percent of area extrapolated from AUC last to infinity were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite percent of area extrapolated from AUC last to infinity (%)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.'}, {'measure': 'PK: Apparent Terminal Elimination Half-life', 'timeFrame': 'Apparent terminal elimination half-life were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite apparent terminal elimination half-life (h)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.'}, {'measure': 'PK: Apparent Plasma Clearance', 'timeFrame': 'Apparent plasma clearance were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite apparent plasma clearance CL/F (mL/h)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.'}, {'measure': 'PK: Apparent Volume of Distribution', 'timeFrame': 'Apparent volume of distribution were calculated based on all above results for Day 1 and Day 29 (Week 4).', 'description': 'VIR-2218 and metabolite apparent volume of distribution Vz/F (mL)\n\nVIR-2218 and metabolite concentrations were tested at predose on Day 1 and 1h, 2h, 4h, 8h, and 24h postdose, Week 1, predose on Week 4 and 1h, 2h, 4h, 8h, and 24h postdose, Week 5, Week 8, Week 16, and Week 24.'}, {'measure': 'Maximum Change of Serum HBsAg From Baseline', 'timeFrame': 'up to 16 weeks', 'description': 'Maximum change of serum HBsAg from Day 1 until 12 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline)'}, {'measure': 'Number of Participants With Serum HBsAg Loss', 'timeFrame': 'up to 48 weeks', 'description': 'Number of participants with serum HBsAg \\< 0.05 IU/mL at two or more consecutive measurements'}, {'measure': 'Number of Participants With Sustained Serum HBsAg Loss for at Least 6 Months', 'timeFrame': 'up to 48 weeks', 'description': 'Number of participants with sustained serum HBsAg \\< 0.05 IU/mL at all visits for at least 6 months'}, {'measure': 'Number of Participants With Anti-HBs Seroconversion at Any Timepoint', 'timeFrame': 'up to 48 weeks', 'description': 'Anti-HBs seroconversion is defined as anti-HBs positivity at two or more consecutive measurements'}, {'measure': 'For HBeAg-positive Subjects: Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint', 'timeFrame': 'up to 48 weeks', 'description': 'HBeAg loss is defined as quantitative HBeAg \\< 0.14 IU/mL at two or more consecutive measurements. Anti-HBe seroconversion is defined as anti-HBe positivity at two or more consecutive measurements.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis B Virus', 'Chronic Hepatitis B', 'HBV', 'Hepatitis'], 'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female age 18 - 65;\n* Weight ≥ 40 kg to ≤ 125 kg;\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 injection;\n* History of chronic liver disease from any cause other than chronic HBV infection;\n* History of hepatic decompensation;'}, 'identificationModule': {'nctId': 'NCT04507269', 'briefTitle': 'Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Brii Biosciences Limited'}, 'officialTitle': 'A Phase 2 Randomized, Placebo-Controlled Study in Mainland China to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218', 'orgStudyIdInfo': {'id': 'VIR-2218-1005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIR-2218', 'description': 'Drug: VIR-2218 VIR-2218 given by subcutaneous injection', 'interventionNames': ['Drug: VIR-2218']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug: Placebo Saline given by subcutaneous injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VIR-2218', 'type': 'DRUG', 'description': 'VIR-2218 given by subcutaneous injection', 'armGroupLabels': ['VIR-2218']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline given by subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Investigative Site', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], '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': 'Alnylam Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}