Viewing Study NCT02862106

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-26 @ 3:59 PM
Ignite Modification Date: 2026-02-24 @ 8:50 AM
Study NCT ID: NCT02862106
Status: COMPLETED
Last Update Posted: 2019-08-20
First Post: 2016-08-06
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'wuyuzhang@yahoo.com', 'phone': '02368752230', 'title': 'Dr.Wu', 'phoneExt': '86', 'organization': 'Institute of Immunology，PLA'}, 'certainAgreement': {'otherDetails': "Investigators can't publish articles relevant to the study unless the sponsor permits.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Follow-up Group', 'description': 'Do not give any intervention, follow-up observation only All safety analyzes were analyzed in a safe population, and since 1 subjects had no safety data, they were excluded from the safety population', 'otherNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'εPA-44 900μg Group', 'description': 'Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 All safety analyzes were analyzed in a safe population, and since 5 subjects had no safety data, they were excluded from the safety population', 'otherNumAtRisk': 178, 'otherNumAffected': 43, 'seriousNumAtRisk': 178, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ALT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'AST increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Leukocytes in urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Elevated transaminase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mouth ulcers', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gum pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gingival swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chronic nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Severe chronic hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute exacerbation of Chronic hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-up Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG001', 'title': 'Follow-up Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG002', 'title': 'Follow-up Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG003', 'title': 'εPA-44 900μg Group-placebo', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG004', 'title': 'εPA-44 900μg Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG005', 'title': 'εPA-44 900μg Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '38.7', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '34.5', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Endpoint (LOCF), up to 144 weeks', 'description': 'Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-up Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG001', 'title': 'Follow-up Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG002', 'title': 'Follow-up Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG003', 'title': 'εPA-44 900μg Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG004', 'title': 'εPA-44 900μg Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG005', 'title': 'εPA-44 900μg Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}], 'classes': [{'title': 'Week 95', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '25.8', 'groupId': 'OG003'}, {'value': '21.8', 'groupId': 'OG004'}, {'value': '34.5', 'groupId': 'OG005'}]}]}, {'title': 'Week 108', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '55.6', 'groupId': 'OG002'}, {'value': '32.3', 'groupId': 'OG003'}, {'value': '32.7', 'groupId': 'OG004'}, {'value': '34.5', 'groupId': 'OG005'}]}]}, {'title': 'Week 120', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '72.7', 'groupId': 'OG001'}, {'value': '44.4', 'groupId': 'OG002'}, {'value': '29.0', 'groupId': 'OG003'}, {'value': '30.9', 'groupId': 'OG004'}, {'value': '25.9', 'groupId': 'OG005'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '81.8', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '37.1', 'groupId': 'OG003'}, {'value': '32.7', 'groupId': 'OG004'}, {'value': '27.6', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week95,108,120,144', 'unitOfMeasure': 'percentage of paricipant', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population'}, {'type': 'SECONDARY', 'title': 'The Proportion of Patients With Both Negative HBeAg and HBeAb.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-up Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG001', 'title': 'Follow-up Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG002', 'title': 'Follow-up Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG003', 'title': 'εPA-44 900μg Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG004', 'title': 'εPA-44 900μg Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG005', 'title': 'εPA-44 900μg Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}], 'classes': [{'title': 'Week 95', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1.7', 'groupId': 'OG005'}]}]}, {'title': 'Week 108', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3.2', 'groupId': 'OG003'}, {'value': '3.6', 'groupId': 'OG004'}, {'value': '1.7', 'groupId': 'OG005'}]}]}, {'title': 'Week 120', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4.8', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3.4', 'groupId': 'OG005'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4.8', 'groupId': 'OG003'}, {'value': '3.6', 'groupId': 'OG004'}, {'value': '6.9', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week95,108,120,144', 'unitOfMeasure': 'percentage of paricipants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat population'}, {'type': 'SECONDARY', 'title': 'The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-up Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG001', 'title': 'Follow-up Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG002', 'title': 'Follow-up Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG003', 'title': 'εPA-44 900μg Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG004', 'title': 'εPA-44 900μg Group-εPA-44 600μg', 'description': 'These subjects from theεPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG005', 'title': 'εPA-44 900μg Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}], 'classes': [{'title': 'Week 95', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Week 108', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Week 120', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week95,108,120,144', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat population'}, {'type': 'SECONDARY', 'title': 'The Proportion of Patients With Both Negative HBsAg and HBsAb.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-up Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG001', 'title': 'Follow-up Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG002', 'title': 'Follow-up Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG003', 'title': 'εPA-44 900μg Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG004', 'title': 'εPA-44 900μg Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG005', 'title': 'εPA-44 900μg Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}], 'classes': [{'title': 'Week 95', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Week 108', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Week 120', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week95,108,120,144', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-up Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG001', 'title': 'Follow-up Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG002', 'title': 'Follow-up Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG003', 'title': 'εPA-44 900μg Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG004', 'title': 'εPA-44 900μg Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG005', 'title': 'εPA-44 900μg Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}], 'classes': [{'title': 'Week 95', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '90.9', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '25.8', 'groupId': 'OG003'}, {'value': '30.9', 'groupId': 'OG004'}, {'value': '36.2', 'groupId': 'OG005'}]}]}, {'title': 'Week 108', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '90.9', 'groupId': 'OG001'}, {'value': '55.6', 'groupId': 'OG002'}, {'value': '33.9', 'groupId': 'OG003'}, {'value': '25.5', 'groupId': 'OG004'}, {'value': '34.5', 'groupId': 'OG005'}]}]}, {'title': 'Week 120', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '63.6', 'groupId': 'OG001'}, {'value': '44.4', 'groupId': 'OG002'}, {'value': '32.3', 'groupId': 'OG003'}, {'value': '23.6', 'groupId': 'OG004'}, {'value': '29.3', 'groupId': 'OG005'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '63.6', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '35.5', 'groupId': 'OG003'}, {'value': '30.9', 'groupId': 'OG004'}, {'value': '39.7', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week95,108,120,144', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline by Visit for Serum HBV DNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-up Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG001', 'title': 'Follow-up Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG002', 'title': 'Follow-up Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG003', 'title': 'εPA-44 900μg Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG004', 'title': 'εPA-44 900μg Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG005', 'title': 'εPA-44 900μg Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}], 'classes': [{'title': 'Baseline values of log', 'categories': [{'measurements': [{'value': '8.1', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '0.97', 'groupId': 'OG001'}, {'value': '7.5', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '7.8', 'spread': '0.88', 'groupId': 'OG003'}, {'value': '8.1', 'spread': '0.9', 'groupId': 'OG004'}, {'value': '8.0', 'spread': '0.99', 'groupId': 'OG005'}]}]}, {'title': 'Week 95 decreases from baseline', 'categories': [{'measurements': [{'value': '6.0', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '0.92', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '1.83', 'groupId': 'OG003'}, {'value': '2.7', 'spread': '2.18', 'groupId': 'OG004'}, {'value': '2.9', 'spread': '2.34', 'groupId': 'OG005'}]}]}, {'title': 'week 108 decreases from baseline', 'categories': [{'measurements': [{'value': '6.3', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '0.71', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '2.10', 'groupId': 'OG003'}, {'value': '3.1', 'spread': '2.17', 'groupId': 'OG004'}, {'value': '3.2', 'spread': '2.40', 'groupId': 'OG005'}]}]}, {'title': 'week 120 decreases from baseline', 'categories': [{'measurements': [{'value': '5.5', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '0.83', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '2.19', 'groupId': 'OG003'}, {'value': '3.3', 'spread': '1.94', 'groupId': 'OG004'}, {'value': '2.8', 'spread': '2.66', 'groupId': 'OG005'}]}]}, {'title': 'week 144 decreases from baseline', 'categories': [{'measurements': [{'value': '5.6', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '1.21', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '2.27', 'groupId': 'OG003'}, {'value': '4.1', 'spread': '1.77', 'groupId': 'OG004'}, {'value': '3.3', 'spread': '2.69', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week95,108,120,144', 'unitOfMeasure': 'log_10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-up Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG001', 'title': 'Follow-up Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG002', 'title': 'Follow-up Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG003', 'title': 'εPA-44 900μg Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG004', 'title': 'εPA-44 900μg Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG005', 'title': 'εPA-44 900μg Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}], 'classes': [{'title': 'Week 95', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '59.7', 'groupId': 'OG003'}, {'value': '52.7', 'groupId': 'OG004'}, {'value': '60.3', 'groupId': 'OG005'}]}]}, {'title': 'Week 108', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '55.6', 'groupId': 'OG002'}, {'value': '61.3', 'groupId': 'OG003'}, {'value': '60.0', 'groupId': 'OG004'}, {'value': '60.3', 'groupId': 'OG005'}]}]}, {'title': 'Week 120', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '72.7', 'groupId': 'OG001'}, {'value': '44.4', 'groupId': 'OG002'}, {'value': '54.8', 'groupId': 'OG003'}, {'value': '58.2', 'groupId': 'OG004'}, {'value': '43.1', 'groupId': 'OG005'}]}]}, {'title': 'Week 144', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '81.8', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '61.2', 'groupId': 'OG003'}, {'value': '58.2', 'groupId': 'OG004'}, {'value': '55.2', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week95,108,120,144', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline by Vsit for HBeAg Titer.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-up Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG001', 'title': 'Follow-up Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG002', 'title': 'Follow-up Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'OG003', 'title': 'εPA-44 900μg Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG004', 'title': 'εPA-44 900μg Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'OG005', 'title': 'εPA-44 900μg Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}], 'classes': [{'title': 'baseline of HBeAg titers', 'categories': [{'measurements': [{'value': '1276.5', 'spread': '1447.33', 'groupId': 'OG000'}, {'value': '758.5', 'spread': '1287.52', 'groupId': 'OG001'}, {'value': '285.9', 'spread': '411.9', 'groupId': 'OG002'}, {'value': '681.9', 'spread': '658.52', 'groupId': 'OG003'}, {'value': '958.3', 'spread': '929.45', 'groupId': 'OG004'}, {'value': '880.9', 'spread': '1368.65', 'groupId': 'OG005'}]}]}, {'title': 'Week 95 decreases from baseline', 'categories': [{'measurements': [{'value': '-1276.3', 'spread': '1447.33', 'groupId': 'OG000'}, {'value': '-758.3', 'spread': '1287.52', 'groupId': 'OG001'}, {'value': '-285.7', 'spread': '411.9', 'groupId': 'OG002'}, {'value': '-435.8', 'spread': '685.25', 'groupId': 'OG003'}, {'value': '-617.1', 'spread': '913.09', 'groupId': 'OG004'}, {'value': '-550.7', 'spread': '1834.16', 'groupId': 'OG005'}]}]}, {'title': 'week 108 decreases from baseline', 'categories': [{'measurements': [{'value': '-446.3', 'spread': '237.59', 'groupId': 'OG000'}, {'value': '-758.3', 'spread': '1287.52', 'groupId': 'OG001'}, {'value': '-38.9', 'spread': '49.73', 'groupId': 'OG002'}, {'value': '-476.8', 'spread': '728.21', 'groupId': 'OG003'}, {'value': '-807.0', 'spread': '1011.18', 'groupId': 'OG004'}, {'value': '-602.9', 'spread': '1755.50', 'groupId': 'OG005'}]}]}, {'title': 'week 120 decreases from baseline', 'categories': [{'measurements': [{'value': '-446.3', 'spread': '237.64', 'groupId': 'OG000'}, {'value': '-979.9', 'spread': '1463.54', 'groupId': 'OG001'}, {'value': '-314.4', 'spread': '576.36', 'groupId': 'OG002'}, {'value': '-500.7', 'spread': '654.06', 'groupId': 'OG003'}, {'value': '-769.4', 'spread': '1017.49', 'groupId': 'OG004'}, {'value': '-486.3', 'spread': '927.24', 'groupId': 'OG005'}]}]}, {'title': 'week 144 decreases from baseline', 'categories': [{'measurements': [{'value': '-446.3', 'spread': '237.59', 'groupId': 'OG000'}, {'value': '-923.9', 'spread': '1379.30', 'groupId': 'OG001'}, {'value': '-285.7', 'spread': '411.9', 'groupId': 'OG002'}, {'value': '-546.3', 'spread': '629.66', 'groupId': 'OG003'}, {'value': '-788.4', 'spread': '887.7', 'groupId': 'OG004'}, {'value': '-691.5', 'spread': '1708.44', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week95,108,120,144', 'description': 'Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values', 'unitOfMeasure': 'IU/ML', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intend to treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'εPA-44 900μg', 'description': 'Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128\n\nεPA-44: Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'FG001', 'title': 'Follow-up Group', 'description': 'Do not give any intervention, follow-up observation only'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subjects moved to other city', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants completed the first stage(0-76weeks),enrolled at 9 sites in the China. The first participant was screened on 19 November 2011.', 'preAssignmentDetails': '209 participants entered the second stage of the study , and comprise the Safety Analysis Set and the Full Analysis Set'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '203', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Follow-up Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'BG001', 'title': 'Follow-up Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'BG002', 'title': 'Follow-up Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'id': 'BG003', 'title': 'εPA-44 900μg Group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'BG004', 'title': 'εPA-44 900μg Group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'BG005', 'title': 'εPA-44 900μg Group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128'}, {'id': 'BG006', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '203', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'spread': '6.03', 'groupId': 'BG000'}, {'value': '25.2', 'spread': '4.39', 'groupId': 'BG001'}, {'value': '25.8', 'spread': '8.02', 'groupId': 'BG002'}, {'value': '30.4', 'spread': '7.56', 'groupId': 'BG003'}, {'value': '29.6', 'spread': '9.14', 'groupId': 'BG004'}, {'value': '29.4', 'spread': '7.61', 'groupId': 'BG005'}, {'value': '29.4', 'spread': '7.96', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '50', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '153', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '22.69', 'spread': '4.043', 'groupId': 'BG000'}, {'value': '21.23', 'spread': '2.181', 'groupId': 'BG001'}, {'value': '21.42', 'spread': '2.601', 'groupId': 'BG002'}, {'value': '21.95', 'spread': '2.615', 'groupId': 'BG003'}, {'value': '21.76', 'spread': '3.273', 'groupId': 'BG004'}, {'value': '22.12', 'spread': '2.792', 'groupId': 'BG005'}, {'value': '21.89', 'spread': '2.835', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The safety population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-11', 'studyFirstSubmitDate': '2016-08-06', 'resultsFirstSubmitDate': '2016-11-20', 'studyFirstSubmitQcDate': '2016-08-06', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-20', 'studyFirstPostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period', 'timeFrame': 'Endpoint (LOCF), up to 144 weeks', 'description': 'Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)'}], 'secondaryOutcomes': [{'measure': 'The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144', 'timeFrame': 'week95,108,120,144'}, {'measure': 'The Proportion of Patients With Both Negative HBeAg and HBeAb.', 'timeFrame': 'week95,108,120,144'}, {'measure': 'The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144', 'timeFrame': 'week95,108,120,144'}, {'measure': 'The Proportion of Patients With Both Negative HBsAg and HBsAb.', 'timeFrame': 'week95,108,120,144'}, {'measure': 'The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit', 'timeFrame': 'week95,108,120,144'}, {'measure': 'Change From Baseline by Visit for Serum HBV DNA', 'timeFrame': 'week95,108,120,144'}, {'measure': 'Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales;', 'timeFrame': 'week95,108,120,144'}, {'measure': 'Change From Baseline by Vsit for HBeAg Titer.', 'timeFrame': 'week95,108,120,144', 'description': 'Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Hepatitis B', 'HBeAg positive', 'Therapeutic HBV Vaccine', 'HBV-specific Cytotoxic T Lymphocyte'], 'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.', 'detailedDescription': 'Second stage(76-144 weeks):\n\nIn this follow-up stage the trial is open designed, and all the subjects completed the first stage study(0-76 weeks)\n\n1. Subjects with virological response but no serological response/with serological response but no virological response/neither virological nor serological response in the first stage, and be willing to continue the this follow-up study, will be treated by εPA-44 900 μg at week 80,83,86,89,92,95,98,101,104,108,112,116,120,124,128.\n2. Subjects with both virological and serological response, will be followed-up to 144 weeks with no Adefovir Dipivoxil or εPA-44 900 μg treatment.\n\nThe definition of response as below:\n\n1. Virological response: HBV DNA\\<2.93×10∧3IU/ml at 76 weeks;\n2. Serological response: serological conversion of HBeAg at 76 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subjects completed the first stage study(0-76 weeks) and willing to willing to participate in the trial\n2. Uses effective contraception for subject with child-bearing potential (including females and female partners of males)\n3. Understands and signs ICF approved by EC\n4. Willing to comply with the study procedures and complete the study\n\nExclusion Criteria:\n\n1.Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator'}, 'identificationModule': {'nctId': 'NCT02862106', 'briefTitle': 'Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chongqing Jiachen Biotechnology Ltd.'}, 'officialTitle': 'Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients', 'orgStudyIdInfo': {'id': '71006.01-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'εPA-44 900μg group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 InjectεPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128', 'interventionNames': ['Biological: εPA-44']}, {'type': 'EXPERIMENTAL', 'label': 'εPA-44 900μg group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128', 'interventionNames': ['Biological: εPA-44']}, {'type': 'EXPERIMENTAL', 'label': 'εPA-44 900μg group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128', 'interventionNames': ['Biological: εPA-44']}, {'type': 'NO_INTERVENTION', 'label': 'Follow-up group-placebo', 'description': 'These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'type': 'NO_INTERVENTION', 'label': 'Follow-up group-εPA-44 600μg', 'description': 'These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}, {'type': 'NO_INTERVENTION', 'label': 'Follow-up group-εPA-44 900μg', 'description': 'These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only'}], 'interventions': [{'name': 'εPA-44', 'type': 'BIOLOGICAL', 'otherNames': ['Therapeutic HBV vaccine'], 'description': 'subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128', 'armGroupLabels': ['εPA-44 900μg group-placebo', 'εPA-44 900μg group-εPA-44 600μg', 'εPA-44 900μg group-εPA-44 900μg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Renmin Hosptial of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Xiangya Hospital Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': '81th Hospital of PLA', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'XiAn', 'state': 'Shanxi', 'country': 'China', 'facility': 'TangDu Hospital'}, {'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'city': 'Beijing', 'country': 'China', 'facility': '302 Militray Hosptial of China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': "Hepatitis Institute of Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'Southwest Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Lai Wei, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hepatitis Institute of Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing Jiachen Biotechnology Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Third Military Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}