Viewing Study NCT04454567

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Ignite Creation Date: 2025-12-25 @ 12:41 AM
Ignite Modification Date: 2026-01-03 @ 7:56 PM
Study NCT ID: NCT04454567
Status: TERMINATED
Last Update Posted: 2022-10-20
First Post: 2020-06-18
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinicaltrials@assemblybio.com', 'phone': '833-509-4583', 'title': 'Executive Director of Clinical Operations', 'organization': 'Assembly Biosciences'}, 'certainAgreement': {'otherDetails': 'Assembly Biosciences agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Assembly Biosciences supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study ABI-H0731-205 was terminated early by the study Sponsor for strategic reasons to prioritize research and development efforts on finite and curative HBV therapies. At the time of early termination, only 2 participants were enrolled, both of which discontinued their assigned study treatment early due to the study being terminated early by the Sponsor. As a result, the primary outcome of number of participants with HBV DNA \\<LLOQ at Week 48 could not be assessed.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline and up to 5 months', 'eventGroups': [{'id': 'EG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID-19', 'notes': 'COVID-19 infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu like symptoms', 'notes': 'Flu like symptoms secondary to COVID vaccine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 5 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Premature Discontinuation of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 5 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With a Laboratory Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 5 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With HBV DNA <Lower Limit of Quantification (LLOQ) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'timeFrame': 'Week 48', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data for Week 48 were not collected and analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in log10 HBV DNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'timeFrame': 'Baseline and up to 5 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data were not collected and analyzed for secondary outcomes.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HBV DNA <LLOQ at Each Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'timeFrame': 'Baseline and up to 5 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data were not available to analyze the secondary outcomes.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HBV DNA <Limit of Detection (LOD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'timeFrame': 'Baseline and up to 5 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data were not analyzed for secondary outcomes.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in log10 HBV Pregenomic RNA (pgRNA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'timeFrame': 'Baseline and up to 5 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data were not analyzed for secondary outcomes.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HBV pgRNA <LLOQ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'timeFrame': 'Baseline and up to 5 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data were not analyzed for secondary outcomes.'}, {'type': 'SECONDARY', 'title': "Mean Change From Baseline in log10 Serum Hepatitis B 'e' Antigen (HBeAg)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'timeFrame': 'Baseline and up to 5 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data were not analyzed for secondary outcomes.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in log10 Serum Hepatitis B Core-related Antigen (HBcrAg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'timeFrame': 'Baseline and up to 5 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data were not analyzed for secondary outcomes.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in log10 Serum Hepatitis B Surface Antigen (HBsAg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'timeFrame': 'Baseline and up to 5 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data were not analyzed for secondary outcomes.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Normalized Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'timeFrame': 'Baseline and up to 5 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data were not analyzed for secondary outcomes.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of ABI-H0731', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'timeFrame': 'Baseline and up to 5 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data were not analyzed for secondary outcomes.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of Entecavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'timeFrame': 'Baseline and up to 5 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data were not analyzed for secondary outcomes.'}, {'type': 'SECONDARY', 'title': 'Incidence of HBV Variants Among Participants With Evidence of Non-response to Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'OG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'timeFrame': 'Baseline and up to 5 months', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data were not analyzed for secondary outcomes.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'FG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'BG001', 'title': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.\n\nABI-H0731: Participants will receive ABI-H0731 tablets orally once daily\n\nPlacebo: Participants will receive placebo to ABI-H0731 tablets orally once daily\n\nNrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Years positive for HBV', 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '24.8', 'spread': '28.567', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Years on HBV treatment at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'BG000'}, {'value': '1.5', 'groupId': 'BG001'}, {'value': '2.55', 'spread': '1.485', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline HBV DNA (Cobas log10 IU/mL)', 'classes': [{'categories': [{'measurements': [{'value': '2.20', 'groupId': 'BG000'}, {'value': '2.06', 'groupId': 'BG001'}, {'value': '2.13', 'spread': '0.099', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline HBV pgRNA (log10 U/mL)', 'classes': [{'categories': [{'measurements': [{'value': '4.85', 'groupId': 'BG000'}, {'value': '6.55', 'groupId': 'BG001'}, {'value': '5.7', 'spread': '1.202', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 U/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline HBeAg (log10 IU/mL)', 'classes': [{'categories': [{'measurements': [{'value': '2.35', 'groupId': 'BG000'}, {'value': '2.82', 'groupId': 'BG001'}, {'value': '2.585', 'spread': '0.332', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline HBcrAg (log10 kU/mL)', 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'groupId': 'BG000'}, {'value': '0.92', 'groupId': 'BG001'}, {'value': '0.905', 'spread': '0.021', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 kU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline HBsAg (log10 IU/mL)', 'classes': [{'categories': [{'measurements': [{'value': '3.81', 'groupId': 'BG000'}, {'value': '4.61', 'groupId': 'BG001'}, {'value': '4.21', 'spread': '0.566', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline ALT (U/L)', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13.5', 'spread': '3.536', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-08', 'size': 1578341, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-04T13:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': "Study stopped due to a change in the Sponsor's overall development strategy from treatment of chronic disease to finite, curative treatments, and is based partially on the advice and feedback from experts and regulators.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-23', 'studyFirstSubmitDate': '2020-06-18', 'resultsFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2020-06-30', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-23', 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With an Adverse Event', 'timeFrame': 'Baseline and up to 5 months'}, {'measure': 'Number of Participants With Premature Discontinuation of Treatment', 'timeFrame': 'Baseline and up to 5 months'}, {'measure': 'Number of Participants With a Laboratory Abnormality', 'timeFrame': 'Baseline and up to 5 months'}, {'measure': 'Number of Participants With HBV DNA <Lower Limit of Quantification (LLOQ) at Week 48', 'timeFrame': 'Week 48'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in log10 HBV DNA', 'timeFrame': 'Baseline and up to 5 months'}, {'measure': 'Number of Participants With HBV DNA <LLOQ at Each Timepoint', 'timeFrame': 'Baseline and up to 5 months'}, {'measure': 'Number of Participants With HBV DNA <Limit of Detection (LOD)', 'timeFrame': 'Baseline and up to 5 months'}, {'measure': 'Mean Change From Baseline in log10 HBV Pregenomic RNA (pgRNA)', 'timeFrame': 'Baseline and up to 5 months'}, {'measure': 'Number of Participants With HBV pgRNA <LLOQ', 'timeFrame': 'Baseline and up to 5 months'}, {'measure': "Mean Change From Baseline in log10 Serum Hepatitis B 'e' Antigen (HBeAg)", 'timeFrame': 'Baseline and up to 5 months'}, {'measure': 'Mean Change From Baseline in log10 Serum Hepatitis B Core-related Antigen (HBcrAg)', 'timeFrame': 'Baseline and up to 5 months'}, {'measure': 'Mean Change From Baseline in log10 Serum Hepatitis B Surface Antigen (HBsAg)', 'timeFrame': 'Baseline and up to 5 months'}, {'measure': 'Number of Participants With Normalized Alanine Aminotransferase (ALT)', 'timeFrame': 'Baseline and up to 5 months'}, {'measure': 'Plasma Concentrations of ABI-H0731', 'timeFrame': 'Baseline and up to 5 months'}, {'measure': 'Plasma Concentrations of Entecavir', 'timeFrame': 'Baseline and up to 5 months'}, {'measure': 'Incidence of HBV Variants Among Participants With Evidence of Non-response to Treatment', 'timeFrame': 'Baseline and up to 5 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'This study will explore the safety and antiviral activity of ABI-H0731 when added to a nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially virologically suppressed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) 18 to 36 kg/m\\^2 and a minimum body weight of 45 kg (inclusive)\n* In good general health except for chronic hepatitis B (CHB)\n* HBeAg positive or HBeAg negative chronic hepatitis B\n* HBV DNA \\>LLOQ using a commercially available assay with LLOQ=20 IU/mL\n* On a stable NrtI regimen (ETV, TDF or TAF) for more than 12 months\n* Lack of cirrhosis or advanced liver disease\n\nExclusion Criteria:\n\n* Current or prior treatment for CHB with lamivudine, telbivudine, adefovir, HBV core inhibitor, or previous treatment with an investigational agent for HBV infection\n* Presence of substitutions in the HBV polymerase coding region which may confer reduced susceptibility to NrtIs\n* Co-infection with human immunodeficiency virus, hepatitis A virus, hepatitis C virus, hepatitis E virus, or hepatitis D virus\n* Females who are lactating or wish to become pregnant during the course of the trial\n* History or evidence of advanced liver disease or hepatic decompensation\n* Clinically significant cardiac disease including poorly-controlled or unstable hypertension; pulmonary disease; chronic or recurrent renal or urinary tract disease; liver disease other than CHB; endocrine disorder; autoimmune disorder; poorly controlled diabetes mellitus; neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment; ongoing infection or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that, in the opinion of the Investigator or the Sponsor, makes the subject unsuitable for trial participation\n* History of hepatocellular carcinoma (HCC)\n* Exclusionary laboratory parameters at Screening:\n\n * Platelet count \\<100,000/mm\\^3\n * Albumin \\<lower limit of normal\n * Total bilirubin \\>1.2 × upper limit of normal (ULN)\n * Direct bilirubin \\>1.2 × ULN\n * ALT \\>10 × ULN\n * Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is \\>ULN but \\<100 ng/mL, the participant is eligible if a hepatic imaging trial prior to initiation of study drug reveals no lesions indicative of possible HCC.\n * International Normalized Ratio \\>1.5 × ULN\n * Glomerular filtration rate \\<50 mL/min/1.73 m\\^2 by Chronic Kidney Disease Epidemiology Collaboration equation\n * Any other laboratory abnormality deemed clinically significant by the Sponsor or the Investigator.'}, 'identificationModule': {'nctId': 'NCT04454567', 'briefTitle': 'A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Assembly Biosciences'}, 'officialTitle': 'A Phase 2a, Multi-Center, Single-Blind, Placebo-Controlled Study Evaluating Treatment Intensification With ABI-H0731 in Subjects With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors', 'orgStudyIdInfo': {'id': 'ABI-H0731-205'}, 'secondaryIdInfos': [{'id': 'UTN 1111-1251-7136', 'type': 'OTHER', 'domain': 'World Health Organization'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABI-H0731 + SOC NrtI', 'description': 'Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).', 'interventionNames': ['Drug: ABI-H0731', 'Drug: NrtI']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + SOC NrtI', 'description': 'Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.', 'interventionNames': ['Drug: ABI-H0731', 'Drug: Placebo', 'Drug: NrtI']}], 'interventions': [{'name': 'ABI-H0731', 'type': 'DRUG', 'description': 'Participants will receive ABI-H0731 tablets orally once daily', 'armGroupLabels': ['ABI-H0731 + SOC NrtI', 'Placebo + SOC NrtI']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive placebo to ABI-H0731 tablets orally once daily', 'armGroupLabels': ['Placebo + SOC NrtI']}, {'name': 'NrtI', 'type': 'DRUG', 'otherNames': ['Nucleos(t)ide reverse transcriptase inhibitor'], 'description': 'Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert', 'armGroupLabels': ['ABI-H0731 + SOC NrtI', 'Placebo + SOC NrtI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Asia Pacific Liver Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'California Liver Research Institute', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '92115', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research and Education', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Quest Clinical Research', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Schiff Center for Liver Disease', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Institute of Human Virology', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '08844', 'city': 'Hillsborough', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Infectious Disease Care', 'geoPoint': {'lat': 40.4776, 'lon': -74.62682}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Office of X.M., MD', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '1010', 'city': 'Grafton', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland Clinical Studies', 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}], 'overallOfficials': [{'name': 'Steven Knox', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assembly Biosciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assembly Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}