Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 11:22 AM
Study NCT ID:
NCT03852433
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2019-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019701', 'term': 'Hepatitis D, Chronic'}], 'ancestors': [{'id': 'D003699', 'term': 'Hepatitis D'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'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': 'C000718249', 'term': 'bulevirtide'}, {'id': 'C571888', 'term': 'myrcludex-B'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality: Up to approximately 144 weeks; Adverse events: Pegylated Interferon Alfa-2a (PEG-IFN Alfa) arm: Week 48 plus 30 days; all other arms: Week 96 plus 30 days', 'description': 'All-cause moratlity: Participants from All Randomized Set with available data were analyzed.\n\nAdverse events: Safety Analysis Set included all participants who took at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Pegylated Interferon Alfa-2a (PEG-IFN Alfa)', 'description': 'Participants received PEG-IFN alfa 180 microgram (mcg) once a week for 48 weeks.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 25, 'otherNumAffected': 22, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Bulevirtide 2 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 2 mg once a day in combination with PEG-IFN alfa 180 mcg once a week for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 49, 'seriousNumAtRisk': 50, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Bulevirtide 10 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 10 mg once a day in combination with PEG-IFN alfa 180 mcg once a week for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 50, 'seriousNumAtRisk': 50, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Bulevirtide 10 mg/Day', 'description': 'Participants received bulevirtide 10 mg once a day for 96 weeks.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 37, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Presbyopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Retinal vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hepatic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alpha-2 macroglobulin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bile acids increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Prothrombin level decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Covid-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hepatitis B reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Injection site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anaplastic astrocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a (PEG-IFN Alfa)', 'description': 'Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.'}, {'id': 'OG001', 'title': 'Bulevirtide 2 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 2 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG002', 'title': 'Bulevirtide 10 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG003', 'title': 'Bulevirtide 10 mg/Day', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '37.4'}, {'value': '32.0', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '46.7'}, {'value': '46.0', 'groupId': 'OG002', 'lowerLimit': '31.8', 'upperLimit': '60.7'}, {'value': '12.0', 'groupId': 'OG003', 'lowerLimit': '4.5', 'upperLimit': '24.3'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.0', 'ciLowerLimit': '14.6', 'ciUpperLimit': '50.4', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2631', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.3', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '34.2', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0197', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.3', 'ciLowerLimit': '1.8', 'ciUpperLimit': '48.2', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.7186', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.7', 'ciLowerLimit': '-26.3', 'ciUpperLimit': '11.8', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2184', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.0', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '32.7', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0283', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.0', 'ciLowerLimit': '-36.1', 'ciUpperLimit': '-3.5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after EOT (Week 72 for Arm A and study Week 120 for Arms B, C, and D)', 'description': 'SVR24 was defined as undetectable hepatitis delta virus (HDV) RNA (HDV RNA value \\< lower limit of quantitation \\[LLOQ\\] with target not detected) at 24 weeks after the scheduled end of treatment (EOT).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, is defined as all randomized participants who received at least 1 dose of study drug (Peg-IFNα and/or BLV).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Undetectable HDV RNA at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a (PEG-IFN Alfa)', 'description': 'Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.'}, {'id': 'OG001', 'title': 'Bulevirtide 2 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 2 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG002', 'title': 'Bulevirtide 10 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG003', 'title': 'Bulevirtide 10 mg/Day', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '42.2'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '26.4', 'upperLimit': '54.8'}, {'value': '60.0', 'groupId': 'OG002', 'lowerLimit': '45.2', 'upperLimit': '73.6'}, {'value': '10.0', 'groupId': 'OG003', 'lowerLimit': '3.3', 'upperLimit': '21.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Undetectable HDV RNA at Week 48 means undetectable (\\< LLOQ, target not detected) HDV RNA at Week 48.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Undetectable HDV RNA at Week 96 (Arms B, C, and D Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bulevirtide 2 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 2 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG001', 'title': 'Bulevirtide 10 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG002', 'title': 'Bulevirtide 10 mg/Day', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '58.7'}, {'value': '70.0', 'groupId': 'OG001', 'lowerLimit': '55.4', 'upperLimit': '82.1'}, {'value': '22.0', 'groupId': 'OG002', 'lowerLimit': '11.5', 'upperLimit': '36.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': 'Undetectable HDV RNA at Week 96 means undetectable (\\< LLOQ, target not detected) HDV RNA at Week 96.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Full Analysis Set were analyzed. Per prespecified analysis, the data for this outcome measure was collected only for Arms B, C, and D at the scheduled Week 96 visit. Hence the data for Arm A is not reported for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Combined Response at Week 24 After the Scheduled End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a (PEG-IFN Alfa)', 'description': 'Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.'}, {'id': 'OG001', 'title': 'Bulevirtide 2 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 2 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG002', 'title': 'Bulevirtide 10 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional48 weeks follow-up'}, {'id': 'OG003', 'title': 'Bulevirtide 10 mg/Day', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '42.2'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '22.9', 'upperLimit': '50.8'}, {'value': '52.0', 'groupId': 'OG002', 'lowerLimit': '37.4', 'upperLimit': '66.3'}, {'value': '26.0', 'groupId': 'OG003', 'lowerLimit': '14.6', 'upperLimit': '40.3'}]}]}], 'analyses': [{'pValue': '0.0134', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.0', 'ciLowerLimit': '6.0', 'ciUpperLimit': '44.0', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after EOT (Week 72 for Arm A and Week 120 for Arms B, C, and D)', 'description': 'Combined response was defined as fulfilment of 2 conditions simultaneously: 1) undetectable HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline, alanine aminotransferase (ALT) normalization, defined as an ALT value within the normal range, based on the central laboratories \\[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\\]).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Combined Response at Week 48 After the Scheduled End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a (PEG-IFN Alfa)', 'description': 'Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.'}, {'id': 'OG001', 'title': 'Bulevirtide 2 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 2 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG002', 'title': 'Bulevirtide 10 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG003', 'title': 'Bulevirtide 10 mg/Day', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '15.6', 'upperLimit': '55.3'}, {'value': '32.0', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '46.7'}, {'value': '46.0', 'groupId': 'OG002', 'lowerLimit': '31.8', 'upperLimit': '60.7'}, {'value': '18.0', 'groupId': 'OG003', 'lowerLimit': '8.6', 'upperLimit': '31.4'}]}]}], 'analyses': [{'pValue': '0.0049', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.0', 'ciLowerLimit': '8.2', 'ciUpperLimit': '45.1', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks after EOT (Week 96 for Arm A and Week 144 for Arm B, C, and D)', 'description': 'Combined response is defined as fulfilment of 2 conditions simultaneously: 1) undetectable HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline, ALT normalization, defined as an ALT value within the normal range, based on the central laboratories \\[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\\]).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virological Response 48 After the Scheduled End of Treatment (SVR 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a (PEG-IFN Alfa)', 'description': 'Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.'}, {'id': 'OG001', 'title': 'Bulevirtide 2 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 2 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG002', 'title': 'Bulevirtide 10 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG003', 'title': 'Bulevirtide 10 mg/Day', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '46.7'}, {'value': '26.0', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '40.3'}, {'value': '46.0', 'groupId': 'OG002', 'lowerLimit': '31.8', 'upperLimit': '60.7'}, {'value': '12.0', 'groupId': 'OG003', 'lowerLimit': '4.5', 'upperLimit': '24.3'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.0', 'ciLowerLimit': '14.6', 'ciUpperLimit': '50.4', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-22.8', 'ciUpperLimit': '21.4', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1265', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.0', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '42.2', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1863', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.0', 'ciLowerLimit': '-35.3', 'ciUpperLimit': '5.4', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0601', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.0', 'ciLowerLimit': '1.0', 'ciUpperLimit': '38.2', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1247', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.0', 'ciLowerLimit': '-29.9', 'ciUpperLimit': '1.7', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks after EOT (Week 96 for Arm A; Week 144 for Arms B, C, and D)', 'description': 'SVR 48 is defined as undetectable hepatitis delta virus (HDV) RNA (HDV RNA value \\< lower limit of quantitation \\[LLOQ\\] with target not detected) at 48 weeks after the scheduled end of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Liver Stiffness as Measured by Elastography at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a (PEG-IFN Alfa)', 'description': 'Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.'}, {'id': 'OG001', 'title': 'Bulevirtide 2 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 2 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG002', 'title': 'Bulevirtide 10 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG003', 'title': 'Bulevirtide 10 mg/Day', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'groupId': 'OG000', 'lowerLimit': '-2.29', 'upperLimit': '2.25'}, {'value': '-1.85', 'groupId': 'OG001', 'lowerLimit': '-3.42', 'upperLimit': '-0.28'}, {'value': '-1.79', 'groupId': 'OG002', 'lowerLimit': '-3.21', 'upperLimit': '-0.36'}, {'value': '-3.34', 'groupId': 'OG003', 'lowerLimit': '-4.84', 'upperLimit': '-1.85'}]}]}], 'analyses': [{'pValue': '0.0717', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '3.26', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1563', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.84', 'ciLowerLimit': '-4.39', 'ciUpperLimit': '0.71', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1626', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.80', 'ciLowerLimit': '-4.33', 'ciUpperLimit': '0.73', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0099', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.34', 'ciLowerLimit': '-5.87', 'ciUpperLimit': '-0.82', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9384', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-1.67', 'ciUpperLimit': '1.81', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0875', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.49', 'ciLowerLimit': '-3.20', 'ciUpperLimit': '0.22', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'The mixed-effects models for repeated measurements (MMRM) model was used for analysis.', 'unitOfMeasure': 'kPa', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Full Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Liver Stiffness as Measured by Elastography at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Bulevirtide 2 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 2 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG001', 'title': 'Bulevirtide 10 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG002', 'title': 'Bulevirtide 10 mg/Day', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.37', 'groupId': 'OG000', 'lowerLimit': '-4.94', 'upperLimit': '-1.80'}, {'value': '-3.70', 'groupId': 'OG001', 'lowerLimit': '-5.11', 'upperLimit': '-2.29'}, {'value': '-3.85', 'groupId': 'OG002', 'lowerLimit': '-5.35', 'upperLimit': '-2.35'}]}]}], 'analyses': [{'pValue': '0.8645', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-1.54', 'ciUpperLimit': '1.83', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.7033', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-2.06', 'ciUpperLimit': '1.39', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.5806', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-2.18', 'ciUpperLimit': '1.23', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 96', 'description': 'The MMRM model was used for analysis.', 'unitOfMeasure': 'kPa', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Full Analysis Set with available data were analyzed. Per prespecified analysis, the data for this outcome measure was collected only for Arms B, C, and D at the scheduled Week 96 visit. Hence the data for Arm A is not reported for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Liver Stiffness as Measured by Elastography at Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a (PEG-IFN Alfa)', 'description': 'Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.'}, {'id': 'OG001', 'title': 'Bulevirtide 2 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 2 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG002', 'title': 'Bulevirtide 10 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'OG003', 'title': 'Bulevirtide 10 mg Once a Day', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.31', 'groupId': 'OG000', 'lowerLimit': '-2.75', 'upperLimit': '2.12'}, {'value': '-2.35', 'groupId': 'OG001', 'lowerLimit': '-4.20', 'upperLimit': '-0.50'}, {'value': '-2.47', 'groupId': 'OG002', 'lowerLimit': '-4.12', 'upperLimit': '-0.83'}, {'value': '-0.79', 'groupId': 'OG003', 'lowerLimit': '-2.53', 'upperLimit': '0.94'}]}]}], 'analyses': [{'pValue': '0.1103', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.68', 'ciLowerLimit': '-3.75', 'ciUpperLimit': '0.39', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1533', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.05', 'ciLowerLimit': '-4.88', 'ciUpperLimit': '0.77', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1129', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.22', 'ciLowerLimit': '-4.98', 'ciUpperLimit': '0.53', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.6753', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-3.34', 'ciUpperLimit': '2.17', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.9124', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-2.28', 'ciUpperLimit': '2.04', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.1526', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '3.70', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 48 weeks after EOT (Week 96 for Arm A and study Week 144 for Arms B, C, and D)', 'description': 'The MMRM model was used for analysis.', 'unitOfMeasure': 'kPa', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from Full Analysis Set were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pegylated Interferon Alfa-2a (PEG-IFN Alfa)', 'description': 'Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.'}, {'id': 'FG001', 'title': 'Bulevirtide 2 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 2 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'FG002', 'title': 'Bulevirtide 10 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 10 mg once day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up.\n\n.'}, {'id': 'FG003', 'title': 'Bulevirtide 10 mg/Day', 'description': 'Participants received bulevirtide 10 mg once day subcutaneously for 96 weeks with additional 48 weeks follow-up.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized but never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in the France, Moldova, Romania and Russia.', 'preAssignmentDetails': '258 participants were screened. Participants were assigned to arms A: Pegylated Interferon Alfa-2a (PEG-IFN Alfa), B: Bulevirtide 2 mg/Day + PEG-IFN Alfa, C: Bulevirtide 10 mg/Day + PEG-IFN Alfa and D: Bulevirtide 10 mg/Day to the respective treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Pegylated Interferon Alfa-2a (PEG-IFN Alfa)', 'description': 'Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.'}, {'id': 'BG001', 'title': 'Bulevirtide 2 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 2 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'BG002', 'title': 'Bulevirtide 10 mg/Day + PEG-IFN Alfa', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up.'}, {'id': 'BG003', 'title': 'Bulevirtide 10 mg/Day', 'description': 'Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.'}, {'id': 'BG004', 'title': 'Total~(N=174)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '41', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '41', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '41', 'spread': '8.6', 'groupId': 'BG002'}, {'value': '40', 'spread': '8.5', 'groupId': 'BG003'}, {'value': '41', 'spread': '8.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '125', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '152', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity, Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Ethnicity data was not collected in this study.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}]}, {'title': 'Romania', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}, {'title': 'Moldova', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HDV RNA', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5.20', 'spread': '1.064', 'groupId': 'BG000'}, {'value': '5.27', 'spread': '1.355', 'groupId': 'BG001'}, {'value': '5.09', 'spread': '1.343', 'groupId': 'BG002'}, {'value': '5.45', 'spread': '1.098', 'groupId': 'BG003'}, {'value': '5.26', 'spread': '1.242', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Full Analysis Set included all randomized participants who took at least 1 dose of study drug.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Liver Stiffness', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '175', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '15.8', 'spread': '11.57', 'groupId': 'BG000'}, {'value': '12.8', 'spread': '6.43', 'groupId': 'BG001'}, {'value': '12.5', 'spread': '7.60', 'groupId': 'BG002'}, {'value': '12.7', 'spread': '6.65', 'groupId': 'BG003'}, {'value': '13.1', 'spread': '7.72', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Participants from Full Analysis Set with available data were analyzed.', 'unitOfMeasure': 'kPa', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All Randomized Analysis Set included all participants who were enrolled (informed consent signed) and randomized in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-08', 'size': 2910280, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-05T07:12', 'hasProtocol': True}, {'date': '2023-11-13', 'size': 1735310, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-05T07:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'dispFirstSubmitDate': '2023-03-24', 'completionDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2019-02-21', 'resultsFirstSubmitDate': '2024-06-24', 'studyFirstSubmitQcDate': '2019-02-21', 'dispFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-26', 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24)', 'timeFrame': '24 weeks after EOT (Week 72 for Arm A and study Week 120 for Arms B, C, and D)', 'description': 'SVR24 was defined as undetectable hepatitis delta virus (HDV) RNA (HDV RNA value \\< lower limit of quantitation \\[LLOQ\\] with target not detected) at 24 weeks after the scheduled end of treatment (EOT).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Undetectable HDV RNA at Week 48', 'timeFrame': 'Week 48', 'description': 'Undetectable HDV RNA at Week 48 means undetectable (\\< LLOQ, target not detected) HDV RNA at Week 48.'}, {'measure': 'Percentage of Participants With Undetectable HDV RNA at Week 96 (Arms B, C, and D Only)', 'timeFrame': 'Week 96', 'description': 'Undetectable HDV RNA at Week 96 means undetectable (\\< LLOQ, target not detected) HDV RNA at Week 96.'}, {'measure': 'Percentage of Participants With Combined Response at Week 24 After the Scheduled End of Treatment', 'timeFrame': '24 weeks after EOT (Week 72 for Arm A and Week 120 for Arms B, C, and D)', 'description': 'Combined response was defined as fulfilment of 2 conditions simultaneously: 1) undetectable HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline, alanine aminotransferase (ALT) normalization, defined as an ALT value within the normal range, based on the central laboratories \\[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\\]).'}, {'measure': 'Percentage of Participants With Combined Response at Week 48 After the Scheduled End of Treatment', 'timeFrame': '48 weeks after EOT (Week 96 for Arm A and Week 144 for Arm B, C, and D)', 'description': 'Combined response is defined as fulfilment of 2 conditions simultaneously: 1) undetectable HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline, ALT normalization, defined as an ALT value within the normal range, based on the central laboratories \\[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\\]).'}, {'measure': 'Percentage of Participants With Sustained Virological Response 48 After the Scheduled End of Treatment (SVR 48)', 'timeFrame': '48 weeks after EOT (Week 96 for Arm A; Week 144 for Arms B, C, and D)', 'description': 'SVR 48 is defined as undetectable hepatitis delta virus (HDV) RNA (HDV RNA value \\< lower limit of quantitation \\[LLOQ\\] with target not detected) at 48 weeks after the scheduled end of treatment.'}, {'measure': 'Change From Baseline in Liver Stiffness as Measured by Elastography at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'The mixed-effects models for repeated measurements (MMRM) model was used for analysis.'}, {'measure': 'Change From Baseline in Liver Stiffness as Measured by Elastography at Week 96', 'timeFrame': 'Baseline, Week 96', 'description': 'The MMRM model was used for analysis.'}, {'measure': 'Change From Baseline in Liver Stiffness as Measured by Elastography at Week 144', 'timeFrame': 'Baseline, 48 weeks after EOT (Week 96 for Arm A and study Week 144 for Arms B, C, and D)', 'description': 'The MMRM model was used for analysis.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis Delta']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Asselah T, Arama SS, Bogomolov P, Bourliere M, Fontaine H, Gherlan GS, et al. Safety and Efficacy of Bulevirtide Monotherapy and in Combination with Peginterferon Alfa-2a in Patients with Chronic Hepatitis Delta: 24 Weeks Interim Data of MYR204 Phase 2b Study [Presentation]. European Association for the Study of the Liver (EASL): The Digital International Liver Congress; 2021 23-26 June.'}, {'pmid': '34482769', 'type': 'BACKGROUND', 'citation': 'Asif B, Koh C. Hepatitis D virus (HDV): investigational therapeutic agents in clinical trials. Expert Opin Investig Drugs. 2022 Sep;31(9):905-920. doi: 10.1080/13543784.2021.1977795. Epub 2021 Oct 1.'}, {'pmid': '36712949', 'type': 'BACKGROUND', 'citation': 'Soriano V, Moreno-Torres V, Trevino A, Corral O, de Mendoza C. Bulevirtide in the Treatment of Hepatitis Delta: Drug Discovery, Clinical Development and Place in Therapy. Drug Des Devel Ther. 2023 Jan 21;17:155-166. doi: 10.2147/DDDT.S379964. eCollection 2023.'}, {'type': 'BACKGROUND', 'citation': 'Asselah T, Lampertico P, Wedemeyer H, Streinu-Cercel A, Pantea V, Lazar S, et al. Efficacy and Safety of Bulevirtide in Combination with Pegylated Interferon alfa-2a in Patients with Chronic Hepatitis Delta: Primary Endpoint Results from a Phase 2b Open-Label, Randomized, Multicenter Study MYR204. [Poster #5009]. AASLD - The Liver Meeting; 2023 November 10-24; Boston, MA.'}, {'pmid': '39648559', 'type': 'DERIVED', 'citation': 'Asselah T, Lampertico P, Aleman S, Bourliere M, Streinu-Cercel A, Bogomolov P, Morozov V, Stepanova T, Lazar S, Manuilov D, Mercier RC, Tseng S, Ye L, Flaherty JF, Osinusi A, Da BL, Chee GM, Lau AH, Brunetto MR, Wedemeyer H. Bulevirtide Monotherapy Is Safe and Well Tolerated in Chronic Hepatitis Delta: An Integrated Safety Analysis of Bulevirtide Clinical Trials at Week 48. Liver Int. 2025 Apr;45(4):e16174. doi: 10.1111/liv.16174. Epub 2024 Dec 8.'}, {'pmid': '38842520', 'type': 'DERIVED', 'citation': 'Asselah T, Chulanov V, Lampertico P, Wedemeyer H, Streinu-Cercel A, Pantea V, Lazar S, Placinta G, Gherlan GS, Bogomolov P, Stepanova T, Morozov V, Syutkin V, Sagalova O, Manuilov D, Mercier RC, Ye L, Da BL, Chee G, Lau AH, Osinusi A, Bourliere M, Ratziu V, Pol S, Hilleret MN, Zoulim F. Bulevirtide Combined with Pegylated Interferon for Chronic Hepatitis D. N Engl J Med. 2024 Jul 11;391(2):133-143. doi: 10.1056/NEJMoa2314134. Epub 2024 Jun 6.'}], 'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study/?id=MYR%20204', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy of bulevirtide in combination with pegylated interferon in participants with chronic hepatitis delta (CHD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of signed and dated informed consent form.\n* Positive serum hepatitis delta virus (HDV) antibody results or polymerase chain reaction (PCR) results for serum/ plasma HDV ribonucleic acid (RNA )for at least 6 months before screening.\n* Positive PCR results for serum/ plasma HDV RNA at screening.\n* Alanine transaminase level \\>1 x upper limit of normal (ULN), but less than 10 x ULN.\n* Serum albumin \\>28 g/L.\n* Thyroid stimulating hormone (TSH) within normal ranges (including on medication for control of thyroid function)\n* Negative urine pregnancy test for females of childbearing potential.\n* Inclusion criteria for female individuals:\n\n * Postmenopausal for at least 2 years, or\n * Surgically sterile (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization), or\n * Abstinence from heterosexual intercourse throughout the treatment period, or\n * Willingness to use highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive) throughout the treatment period and for 6 months after the last dose of the study medication.\n* Male individuals must agree to use a highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive used by female partners) and not to donate sperm throughout the treatment period and for 6 months after the last dose of the study medication.\n\nExclusion Criteria:\n\n* Child-Pugh hepatic insufficiency score of B-C or over 6 points. Note: Child-Pugh hepatic insufficiency score of 6 points is allowed. Only individuals with compensated cirrhosis are allowed. Uncomplicated oesophageal varices allowed; individuals with current bleeding or ligation, or history of bleeding or ligation within the last 2 years are excluded.\n* Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) coinfection. Individuals with HCV antibodies can be enrolled, if screening HCV RNA test is negative.\n* Creatinine clearance \\< 60 mL/min as estimated using Cockcroft-Gault formula.\n* Total bilirubin ≥ 34.2 µmol/L. (Individuals with higher total bilirubin values may be included after the consultation with the Study Medical Monitor, if such elevation can be clearly attributed to Gilbert's syndrome associated with low-grade hyperbilirubinemia.)\n* Evidence of an active or suspected malignancy, or an untreated pre-malignancy disorder, or a history of malignancy within the last 5 years (with the exception of successfully treated carcinoma of the cervix in situ and successfully treated basal cell carcinoma and squamous cell carcinoma not less than 1 year prior to screening \\[and no more than 3 excised skin cancer within the last 5 years prior to screening\\]) or history of hepatic carcinoma.\n* Systemic connective tissue disorders.\n* New York Heart Association (NYHA) class III-IV congestive heart failure.\n* Individuals with uncontrolled arterial hypertension: systolic blood pressure \\> 150 mm Hg and/ or diastolic blood pressure \\> 100 mm Hg at Screening.\n* Previous or unstable concurrent diseases or conditions that prevent individual's enrolment into the study.\n* Individuals with mental disorders or social circumstances that preclude them from following protocol requirements.\n* Current or previous decompensated liver disease, including coagulopathy, hepatic encephalopathy and esophageal varices hemorrhage.\n* One or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's Disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.). Gilbert's syndrome, a benign disorder associated with low-grade hyperbilirubinemia, will not exclude individauls from participation in this trial. Autoimmune hepatitis stigmata attributed to HDV infection in the opinion of the investigator are allowed.\n* White blood cells (WBC) count \\< 3000 cells/mm\\^3 (\\<1500 if African individuals).\n* Absolute neutrophil count \\< 1500 cells/mm\\^3 (\\<1000 if African individuals).\n* Platelet count \\< 90,000 cells/mm\\^3.\n* Haemoglobin \\< 12 g/dL.\n* Use of prohibited psychotropic agents at Screening.\n* Use of interferons within 6 months before Screening.\n* History of solid organ transplantation.\n* Current alcohol abuse or alcohol abuse within 6 months prior to enrolment in this study; current drug addict or history of drug use within 2 years prior to Screening.\n* History of disease requiring regular use of systemic glucocorticosteroids (inhalative glucocorticosteroids are allowed) or other immunosuppressants.\n* Pregnant or breast-feeding females.\n* Participation in another clinical study with investigational drugs within 30 days prior to randomization.\n* Receipt of bulevirtide previously, e.g. in clinical trials.\n* Inability to follow protocol requirements and undergo all protocol procedures. Note: Individuals with medical contraindication for liver biopsy are allowed to participate in this study. Such individuals will exempt from liver biopsy requirements in this study. Individuals receiving prohibited treatment at screening cannot be included into the study unless this treatment is withdrawn prior to randomization.\n* Contraindications, intolerance or hypersensitivity to interferons alfa, genetically engineered E.coli medications, polyethylene glycol or other components of peginterferon alfa-2а.\n* Presence or history of severe retinopathy, significant diabetic or hypertensive retinopathy.\n* Uncontrolled diabetes mellitus.\n* Uncontrolled cardiovascular disorders within 6 months before screening.\n* History of autoimmune disorder (e.g. myositis, hepatitis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, severe psoriasis, rheumatoid arthritis, interstitial nephritis, thyroiditis, and systemic lupus erythematosus)\n* Presence or history of significant psychiatric disorder (e.g. severe depression, suicide attempt, severe neurosis or cognitive disorder).\n* Presence or history of chronic lung disease with respiratory malfunction."}, 'identificationModule': {'nctId': 'NCT03852433', 'briefTitle': 'Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Multicenter, Open-label, Randomized Phase 2b Clinical Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Patients With Chronic Hepatitis Delta', 'orgStudyIdInfo': {'id': 'MYR204'}, 'secondaryIdInfos': [{'id': '2019-001485-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pegylated Interferon alfa-2a (PEG-IFN alfa)', 'description': 'Participants will receive PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.', 'interventionNames': ['Drug: Peginterferon Alfa-2a (PEG-IFN alfa)']}, {'type': 'EXPERIMENTAL', 'label': 'Bulevirtide 2 mg/day + PEG-IFN alfa', 'description': 'Participants will receive bulevirtide 2 mg once a day subcutaneously incombination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up.', 'interventionNames': ['Drug: Bulevirtide', 'Drug: Peginterferon Alfa-2a (PEG-IFN alfa)']}, {'type': 'EXPERIMENTAL', 'label': 'Bulevirtide 10 mg/day + PEG-IFN alfa', 'description': 'Participants will receive bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up.', 'interventionNames': ['Drug: Bulevirtide', 'Drug: Peginterferon Alfa-2a (PEG-IFN alfa)']}, {'type': 'EXPERIMENTAL', 'label': 'Bulevirtide 10 mg once a day', 'description': 'Participants will receive bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up', 'interventionNames': ['Drug: Bulevirtide']}], 'interventions': [{'name': 'Bulevirtide', 'type': 'DRUG', 'otherNames': ['Myrcludex B', 'Hepcludex®'], 'description': 'Administered via subcutaneous injections', 'armGroupLabels': ['Bulevirtide 10 mg once a day', 'Bulevirtide 10 mg/day + PEG-IFN alfa', 'Bulevirtide 2 mg/day + PEG-IFN alfa']}, {'name': 'Peginterferon Alfa-2a (PEG-IFN alfa)', 'type': 'DRUG', 'description': 'Administered via subcutaneous injections', 'armGroupLabels': ['Bulevirtide 10 mg/day + PEG-IFN alfa', 'Bulevirtide 2 mg/day + PEG-IFN alfa', 'Pegylated Interferon alfa-2a (PEG-IFN alfa)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clichy', 'country': 'France', 'facility': 'Hôpital Beaujon-Pavillon Abrami -Sce Hépatologie', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Grenoble', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hospital Croix Rousee', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'Hôpital Saint Joseph Hépato-Gastroentérologie', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Paris', 'country': 'France', 'facility': 'CH Pitié-Salpétrière - Hépato-Gastroentérologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': "Hôpital Cochin - Unité d'Hépatologie Pavillon Achard", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Infectious Clinical Hospital "T. Ciorba", Department 4 / Medical University Department of Infectious Diseases', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Infectious Clinical Hospital "T. Ciorba", Department 5 / Medical University Department of Infectious Diseases', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': '"Matei Bals" National Institute of Infectious Diseases, Hospital department', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': '"Matei Bals" National Institute of Infectious Diseases,Clinical Trials department', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': '"Victor Babes" Centre of Diagnostic and Treatment', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Dr. V. Babes Clinical Hospital of Infectious and Tropical Diseases', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'State Budgetary Educational Institution of Higher Professional Education "South Ural State Medical University" of the Ministry of Healthcare of the Russian Federation', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'city': 'Krasnodar', 'country': 'Russia', 'facility': 'Specialized clinical Infectious diseases Hospital', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal Budget Institute of Science "Central Research Institute for Epidemiology" of Federal Service on Consumers Rights Protection and Human Well-Being Surveillance', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Budgetary Institution National Research Medical Center for Phthisiopulmonology and Infectious Diseases of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'LLC"Clinic of Modern Medicine"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow Regional Scientific and Research Clinical Institute', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'N.V.Sklifosovsky Scientific Research Institute of Emergency care of the Moscow Healthcare Department', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Samara', 'country': 'Russia', 'facility': 'LLC Medical Company "Hepatolog"', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}], 'overallOfficials': [{'name': 'Gilead Medical Monitor', 'role': 'STUDY_CHAIR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}