Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-28 @ 6:57 AM
Study NCT ID:
NCT03576066
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2018-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D006509', 'term': 'Hepatitis B'}], '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': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C413685', 'term': 'entecavir'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'C442442', 'term': 'tenofovir alafenamide'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@assemblybio.com', 'phone': '415-521-3808', 'title': 'Linda Bahr, Sr. Director, Clinical Operations', 'organization': 'Assembly Biosciences'}, 'certainAgreement': {'otherDetails': 'Assembly Biosciences agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Assembly Biosciences supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 36', 'description': 'Safety population', 'eventGroups': [{'id': 'EG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 24, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 8, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Tongue ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hepatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Liver tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'HBeAg-positive Participants: ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'OG001', 'title': 'HBeAg-positive Participants: Placebo + SOC NUC', 'description': 'Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}, {'id': 'OG002', 'title': 'HBeAg-negative Participants: ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants who are HBeAg negative at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'OG003', 'title': 'HBeAg-negative Participants: Placebo + SOC NUC', 'description': 'Virologically suppressed participants who are HBeAg negative at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.48', 'spread': '0.401', 'groupId': 'OG000'}, {'value': '3.57', 'spread': '0.516', 'groupId': 'OG001'}, {'value': '2.99', 'spread': '0.555', 'groupId': 'OG002'}, {'value': '3.35', 'spread': '0.648', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.138', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.054', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '0.133', 'groupId': 'OG002'}, {'value': '-0.00', 'spread': '0.021', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6855', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1750', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'LS mean difference in HBeAg-negative participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'unitOfMeasure': 'Log10 International Units (IU)/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population: all randomized participants. Results were analyzed and reported based on Baseline HBeAg status: positive or negative, for available data at Baseline, Week 24, or both.'}, {'type': 'PRIMARY', 'title': 'Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HBeAg-positive Participants: ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants who are HBeAg positive at Baseline will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'OG001', 'title': 'HBeAg-positive Participants: Placebo + SOC NUC', 'description': 'Virologically suppressed participants who are HBeAg positive at Baseline will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.55', 'spread': '0.980', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.964', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.191', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.193', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2916', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Least squares (LS) mean difference in HBeAg-positive participants: ABI-H0731 + SOC NUC minus placebo + SOC NUC at Week 24', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'unitOfMeasure': 'Log10 International Units (IU)/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. Results were analyzed and reported only for participants who were HBeAg positive at Baseline and had available data at Baseline, Week 24, or both.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With One or More Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'OG001', 'title': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Follow-up (maximum up to Week 36)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all randomized participants who received any amount of study drug'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Premature Study Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'OG001', 'title': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Follow-up (maximum up to Week 36)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With One or More Abnormal Safety Laboratory Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'OG001', 'title': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 36', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Clinically-significant Electrocardiogram Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'OG001', 'title': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Clinically-significant Change in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'OG001', 'title': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and up to Week 24', 'description': 'Vital signs assessed were body temperature, respiratory rate, and pulse rate', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'OG001', 'title': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 24', 'description': 'Abnormal ALT was defined as ≥1.25 x upper limit of normal (34 Units/L for female and 43 Units/L for male participants).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the ITT population with abnormal ALT at Baseline'}, {'type': 'SECONDARY', 'title': 'Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}], 'classes': [{'title': 'Baseline (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.436', 'spread': '2.92', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1390', 'spread': '647', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1390', 'spread': '632', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1330', 'spread': '560', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1330', 'spread': '526', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Results were analyzed and reported only for participants who received ABI-H0731 + SOC NUC and had ABI-H0731 pharmacokinetic data assessments available.'}, {'type': 'SECONDARY', 'title': 'Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'OG001', 'title': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}], 'classes': [{'title': 'Baseline (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.10', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '1.77', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.554', 'spread': '0.261', 'groupId': 'OG000'}, {'value': '0.346', 'spread': '0.124', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.872', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '0.621', 'spread': '0.460', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.583', 'spread': '0.363', 'groupId': 'OG000'}, {'value': '0.704', 'spread': '0.403', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.04', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '0.739', 'spread': '0.0902', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Results were analyzed and reported only for participants who received ETV as their SOC NUC and had ETV pharmacokinetic data assessments available.'}, {'type': 'SECONDARY', 'title': 'Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'OG001', 'title': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}], 'classes': [{'title': 'Baseline (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.67', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '6.52', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '4.73', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '6.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.3', 'spread': '25.3', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '4.52', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '3.66', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.9', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '3.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Results were analyzed and reported only for participants who received TAF as their SOC NUC and had TAF pharmacokinetic data assessments available.'}, {'type': 'SECONDARY', 'title': 'Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'OG001', 'title': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}], 'classes': [{'title': 'Baseline (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.5', 'spread': '52.1', 'groupId': 'OG000'}, {'value': '89.1', 'spread': '71.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.5', 'spread': '49.3', 'groupId': 'OG000'}, {'value': '76.2', 'spread': '21.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.8', 'spread': '58.2', 'groupId': 'OG000'}, {'value': '84.1', 'spread': '60.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.3', 'spread': '68.1', 'groupId': 'OG000'}, {'value': '86.7', 'spread': '47.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.3', 'spread': '45.3', 'groupId': 'OG000'}, {'value': '78.3', 'spread': '44.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Results were analyzed and reported only for participants who received TDF as their SOC NUC and had TDF pharmacokinetic data assessments available.'}, {'type': 'SECONDARY', 'title': 'Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + SOC NUC Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}], 'timeFrame': 'Baseline, Weeks 2, 4, 12, and 24', 'reportingStatus': 'POSTED', 'populationDescription': 'Trough to peak ratios were not calculated due to an insufficient number of optional peak exposure samples.'}, {'type': 'SECONDARY', 'title': 'Trough to Peak Ratios of SOC NUC on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'OG001', 'title': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}], 'timeFrame': 'Baseline, Weeks 2, 4, 12, and 24', 'reportingStatus': 'POSTED', 'populationDescription': 'Trough to peak ratios were not calculated due to an insufficient number of optional peak exposure samples.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with standard of care (SOC) nucleos(t)ide reverse transcriptase inhibitor (NUC) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'FG001', 'title': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.\n\nABI-H0731: Participants will receive 300 mg QD ABI-H0731 tablets orally.\n\nSOC NUC: Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally (QD frequency) as per approved package insert.'}, {'id': 'BG001', 'title': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.\n\nPlacebo Oral Tablet: Participants will receive matching QD placebo tablets orally.\n\nSOC NUC: Participants will receive SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.6', 'spread': '10.26', 'groupId': 'BG000'}, {'value': '46.4', 'spread': '11.32', 'groupId': 'BG001'}, {'value': '45.3', 'spread': '10.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hepatitis B "e" Antigen (HBeAg) status', 'classes': [{'categories': [{'title': 'HBeAg Positive', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'HBeAg Negative', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-09', 'size': 1256403, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-21T18:25', 'hasProtocol': True}, {'date': '2019-08-06', 'size': 1004541, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-12-21T18:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'dispFirstSubmitDate': '2020-06-03', 'completionDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2018-06-06', 'dispFirstSubmitQcDate': '2020-06-03', 'resultsFirstSubmitDate': '2021-01-08', 'studyFirstSubmitQcDate': '2018-07-02', 'dispFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-08', 'studyFirstPostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean log10 Serum HBsAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC', 'timeFrame': 'Baseline to Week 24'}, {'measure': 'Change in Mean log10 Serum HBeAg From Baseline (Day 1) to Week 24 on ABI-H0731 + SOC NUC as Compared to Placebo + SOC NUC', 'timeFrame': 'Baseline to Week 24'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With One or More Adverse Events', 'timeFrame': 'Up to Follow-up (maximum up to Week 36)'}, {'measure': 'Number of Participants With Premature Study Discontinuation', 'timeFrame': 'Up to Follow-up (maximum up to Week 36)'}, {'measure': 'Number of Participants With One or More Abnormal Safety Laboratory Result', 'timeFrame': 'Up to Week 36'}, {'measure': 'Number of Participants With a Clinically-significant Electrocardiogram Abnormality', 'timeFrame': 'Up to Week 24'}, {'measure': 'Number of Participants With a Clinically-significant Change in Vital Signs', 'timeFrame': 'Baseline and up to Week 24', 'description': 'Vital signs assessed were body temperature, respiratory rate, and pulse rate'}, {'measure': 'Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + NUC Therapy as Compared With Placebo + NUC Therapy', 'timeFrame': 'Baseline to Week 24', 'description': 'Abnormal ALT was defined as ≥1.25 x upper limit of normal (34 Units/L for female and 43 Units/L for male participants).'}, {'measure': 'Trough Levels of ABI-H0731 on ABI-H0731 + SOC NUC Therapy', 'timeFrame': 'Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24'}, {'measure': 'Trough Levels of Entecavir (ETV) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy', 'timeFrame': 'Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24'}, {'measure': 'Trough Levels of Tenofovir Alafenamide (TAF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy', 'timeFrame': 'Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24'}, {'measure': 'Trough Levels of Tenofovir Disoproxil Fumarate (TDF) on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy', 'timeFrame': 'Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24'}, {'measure': 'Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + SOC NUC Therapy', 'timeFrame': 'Baseline, Weeks 2, 4, 12, and 24'}, {'measure': 'Trough to Peak Ratios of SOC NUC on ABI-H0731 + SOC NUC Therapy as Compared With Placebo + SOC NUC Therapy', 'timeFrame': 'Baseline, Weeks 2, 4, 12, and 24'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic hepatitis B', 'HBV', 'HBeAg-positive', 'hepatitis B', 'HBeAg-negative', 'vebicorvir', 'VBR'], 'conditions': ['Chronic Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '35460726', 'type': 'DERIVED', 'citation': 'Yuen MF, Agarwal K, Ma X, Nguyen TT, Schiff ER, Hann HL, Dieterich DT, Nahass RG, Park JS, Chan S, Han SB, Gane EJ, Bennett M, Alves K, Evanchik M, Yan R, Huang Q, Lopatin U, Colonno R, Ma J, Knox SJ, Stamm LM, Bonacini M, Jacobson IM, Ayoub WS, Weilert F, Ravendhran N, Ramji A, Kwo PY, Elkhashab M, Hassanein T, Bae HS, Lalezari JP, Fung SK, Sulkowski MS. Safety and efficacy of vebicorvir in virologically suppressed patients with chronic hepatitis B virus infection. J Hepatol. 2022 Sep;77(3):642-652. doi: 10.1016/j.jhep.2022.04.005. Epub 2022 Apr 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC) medication is safe and effective in participants with chronic hepatitis B virus infection (cHBV).', 'detailedDescription': 'This is a Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Participants with cHBV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Male or female between ages 18 and 70 years\n* Virologically-suppressed (defined as HBV DNA ≤limit of quantitation (LOQ) for at least 6 months before screening on SOC NUC therapy\n* HBeAg-positive or HBeAg-negative at screening\n* In good general health except for cHBV\n\nKey Exclusion Criteria:\n\n* Co-infection with HIV, hepatitis C virus (HCV), hepatitis E virus (HEV) or hepatitis D virus (HDV)\n* History or evidence of hepatic decompensation (including gastrointestinal bleeding or esophageal varices) at any time prior to or at time of screening\n* Clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than HBV, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the Investigator or the Sponsor makes the participant unsuitable for the study\n* Previous treatment with an investigational agent for HBV other than ABI-H0731 in the last 6 months before screening\n* History of hepatocellular carcinoma (HCC)\n* Females who are lactating or pregnant or wish to become pregnant are excluded from the study\n* Exclusionary laboratory parameters at screening include:\n\n * Platelet count \\<100,000/mm3\n * Albumin \\<lower limit of normal (LLN)\n * Direct bilirubin \\>1.2×upper limit of normal (ULN)\n * Alanine aminotransferase (ALT) \\>5×ULN at screening\n * International Normalized Ratio (INR) \\>1.5×ULN\n * Glomerular filtration rate (GFR) \\<60 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation'}, 'identificationModule': {'nctId': 'NCT03576066', 'briefTitle': 'A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Assembly Biosciences'}, 'officialTitle': 'A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 as Adjunctive Therapy in Virally-suppressed Patients With Chronic Hepatitis B', 'orgStudyIdInfo': {'id': 'ABI-H0731-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABI-H0731 + SOC NUC', 'description': 'Virologically suppressed participants will receive ABI-H0731 along with SOC NUC (ETV, TDF or TAF) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.', 'interventionNames': ['Drug: ABI-H0731', 'Drug: SOC NUC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + SOC NUC', 'description': 'Virologically suppressed participants will receive matching placebo tablets and continue their SOC NUC (ETV, TDF or TAF) for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.', 'interventionNames': ['Drug: SOC NUC', 'Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'ABI-H0731', 'type': 'DRUG', 'description': 'Participants will receive ABI-H0731 300 mg tablets orally once daily (QD).', 'armGroupLabels': ['ABI-H0731 + SOC NUC']}, {'name': 'SOC NUC', 'type': 'DRUG', 'otherNames': ['Entecavir (ETV)', 'Tenofovir disoproxil fumarate (TDF)', 'Tenofovir alafenamide (TAF)'], 'description': 'Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.', 'armGroupLabels': ['ABI-H0731 + SOC NUC', 'Placebo + SOC NUC']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Participants will receive placebo matching ABI-0731 tablets orally QD.', 'armGroupLabels': ['Placebo + SOC NUC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92118', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Research Center', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Asia Pacific Liver Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92105', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research and Education', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Associates Research Group', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Quest Clinical Research', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Hospital and Clinics', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21228', 'city': 'Catonsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Digestive Disease Associates', 'geoPoint': {'lat': 39.27205, 'lon': -76.73192}}, {'zip': '08844', 'city': 'Hillsborough', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Infectious Disease Care', 'geoPoint': {'lat': 40.4776, 'lon': -74.62682}}, {'zip': '11354', 'city': 'Flushing', 'state': 'New York', 'country': 'United States', 'facility': 'Sing Chan, MD', 'geoPoint': {'lat': 40.76538, 'lon': -73.81736}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Xiaoli Ma, MD', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Toronto', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'country': 'Canada', 'facility': 'Toronto Liver Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Vancouver', 'country': 'Canada', 'facility': 'GI Research Institute', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assembly Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}