Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-25 @ 3:42 PM
Study NCT ID:
NCT00376259
Status:
TERMINATED
Last Update Posted:
2011-06-30
First Post:
2006-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077712', 'term': 'Telbivudine'}, {'id': 'C106812', 'term': 'adefovir dipivoxil'}], 'ancestors': [{'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA).'}}, 'adverseEventsModule': {'description': 'Safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Combination Therapy', 'description': 'Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.', 'otherNumAtRisk': 21, 'otherNumAffected': 14, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Adefovir Monotherapy', 'description': 'Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.', 'otherNumAtRisk': 21, 'otherNumAffected': 11, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Proportion of Participants Who Experienced Virologic Breakthrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.'}, {'id': 'OG001', 'title': 'Adefovir Monotherapy', 'description': 'Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.'}], 'paramType': 'NUMBER', 'timeFrame': '96 Weeks', 'description': 'Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early and no patients received 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.'}, {'id': 'OG001', 'title': 'Adefovir Monotherapy', 'description': 'Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.'}], 'classes': [{'title': 'At Baseline (N = 21, 20)', 'categories': [{'measurements': [{'value': '10.240', 'spread': '1.5750', 'groupId': 'OG000'}, {'value': '10.127', 'spread': '0.9697', 'groupId': 'OG001'}]}]}, {'title': 'At Week 12', 'categories': [{'measurements': [{'value': '4.405', 'spread': '0.9944', 'groupId': 'OG000'}, {'value': '5.515', 'spread': '1.3188', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-5.835', 'spread': '1.6435', 'groupId': 'OG000'}, {'value': '-4.612', 'spread': '1.7725', 'groupId': 'OG001'}]}]}, {'title': 'At Baseline (N = 20, 20)', 'categories': [{'measurements': [{'value': '10.279', 'spread': '1.6058', 'groupId': 'OG000'}, {'value': '10.127', 'spread': '0.9697', 'groupId': 'OG001'}]}]}, {'title': 'At Week 24', 'categories': [{'measurements': [{'value': '3.678', 'spread': '1.0483', 'groupId': 'OG000'}, {'value': '5.161', 'spread': '1.7364', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 24', 'categories': [{'measurements': [{'value': '-6.601', 'spread': '1.7873', 'groupId': 'OG000'}, {'value': '-4.966', 'spread': '2.2851', 'groupId': 'OG001'}]}]}, {'title': 'At Baseline (N = 13, 9)', 'categories': [{'measurements': [{'value': '10.652', 'spread': '1.5203', 'groupId': 'OG000'}, {'value': '10.207', 'spread': '0.7520', 'groupId': 'OG001'}]}]}, {'title': 'At Week 48', 'categories': [{'measurements': [{'value': '3.274', 'spread': '1.0254', 'groupId': 'OG000'}, {'value': '5.272', 'spread': '1.9581', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 48', 'categories': [{'measurements': [{'value': '-7.378', 'spread': '1.9303', 'groupId': 'OG000'}, {'value': '-4.934', 'spread': '2.1153', 'groupId': 'OG001'}]}]}, {'title': 'At Baseline (N = 2, 3)', 'categories': [{'measurements': [{'value': '9.605', 'spread': '0.7990', 'groupId': 'OG000'}, {'value': '10.097', 'spread': '0.1484', 'groupId': 'OG001'}]}]}, {'title': 'At Week 60', 'categories': [{'measurements': [{'value': '3.360', 'spread': '0.3111', 'groupId': 'OG000'}, {'value': '4.330', 'spread': '0.6110', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 60', 'categories': [{'measurements': [{'value': '-6.245', 'spread': '0.4879', 'groupId': 'OG000'}, {'value': '-5.767', 'spread': '0.4650', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks', 'description': 'Efficacy was assessed by the change from baseline in mean HBV DNA concentration after 12, 24, 48 and 60 weeks of treatment.', 'unitOfMeasure': 'Log10 Copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.'}, {'id': 'OG001', 'title': 'Adefovir Monotherapy', 'description': 'Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.'}], 'classes': [{'title': 'Undetectable HBV DNA at week 12', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Undetectable HBV DNA at week 24', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Undetectable HBV DNA at week 48', 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Undetectable HBV DNA at week 60', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Serum ALT normalization at week 12', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Serum ALT normalization at week 24', 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000'}, {'value': '35.0', 'groupId': 'OG001'}]}]}, {'title': 'Serum ALT normalization at week 48', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Serum ALT normalization at week 60', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBeAg loss at week 12', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBeAg loss at week 24', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'HBeAg loss at week 48', 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBeAg loss at week 60', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBeAg seroconversion at week 12', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBeAg seroconversion at week 24', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBeAg seroconversion at week 48', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBeAg seroconversion at week 60', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBsAg loss at week 12', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBsAg loss at week 24', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBsAg loss at week 48', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBsAg loss at week 60', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBsAg seroconversion at week 12', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBsAg seroconversion at week 24', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBsAg seroconversion at week 48', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'HBsAg seroconversion at week 60', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 week, 24 week, 48 week and 60 weeks', 'description': 'Undetectable HBV DNA = HBV DNA \\<300 copies/ml. Serum aminotransferase (ALT) normalization is defined as ALT within normal limits on 2 successive visits for a pt. with an elevated ALT level (\\>=1.0 x ULN) at baseline (BL). Hepatitis B e antigen (HBeAg) loss is defined as the loss of detectable serum HBeAg in a pt. who was HBeAg +ve at BL. HBeAg seroconversion is defined as HBeAg loss with detectable HBeAb. Hepatitis B surface antigen (HBsAg) loss is defined as the loss of detectable serum HBsAg in a pt. who was HBsAg +ve at BL. HBsAg seroconversion is defined as HBsAg loss with detectable HBsAb.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consists of the intent-to-treat population. Analysis of data for each time point includes participants who had both baseline and post baseline observation for that timepoint.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy', 'description': 'Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.'}, {'id': 'OG001', 'title': 'Adefovir Monotherapy', 'description': 'Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': 'The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA). Patients did not receive 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.', 'unitOfMeasure': 'Proportion of Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Combination Therapy', 'description': 'Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.'}, {'id': 'FG001', 'title': 'Adefovir Monotherapy', 'description': 'Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Sponsor request - study termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Patient request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Planned enrollment was 150 patients. At the time of study termination, 43 patients had been enrolled and randomized to study treatment and 42 patients received study drug (21 patients in the combination group and 21 in the monotherapy group).', 'preAssignmentDetails': 'One patient was randomized but never received study drug treatment because he was discontinued on the randomization day due to sponsor request.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Combination Therapy', 'description': 'Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.'}, {'id': 'BG001', 'title': 'Adefovir Monotherapy', 'description': 'Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'spread': '11.82', 'groupId': 'BG000'}, {'value': '39.0', 'spread': '10.93', 'groupId': 'BG001'}, {'value': '37.9', 'spread': '11.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'whyStopped': 'The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'lastUpdateSubmitDate': '2011-06-28', 'studyFirstSubmitDate': '2006-09-13', 'resultsFirstSubmitDate': '2010-12-20', 'studyFirstSubmitQcDate': '2006-09-13', 'lastUpdatePostDateStruct': {'date': '2011-06-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-19', 'studyFirstPostDateStruct': {'date': '2006-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Proportion of Participants Who Experienced Virologic Breakthrough', 'timeFrame': '96 Weeks', 'description': 'Virologic breakthrough is defined as a minimum of 1 log reduction from baseline followed by a 1 log increase from nadir on at least 2 consecutive visits including the last treatment visit.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Hepatitis B Virus (HBV) DNA Concentration', 'timeFrame': 'Baseline to 12 weeks, 24 weeks, 48 weeks and 60 weeks', 'description': 'Efficacy was assessed by the change from baseline in mean HBV DNA concentration after 12, 24, 48 and 60 weeks of treatment.'}, {'measure': 'Percentage of Participants Achieving Specified Clinical and Laboratory Safety Criteria', 'timeFrame': '12 week, 24 week, 48 week and 60 weeks', 'description': 'Undetectable HBV DNA = HBV DNA \\<300 copies/ml. Serum aminotransferase (ALT) normalization is defined as ALT within normal limits on 2 successive visits for a pt. with an elevated ALT level (\\>=1.0 x ULN) at baseline (BL). Hepatitis B e antigen (HBeAg) loss is defined as the loss of detectable serum HBeAg in a pt. who was HBeAg +ve at BL. HBeAg seroconversion is defined as HBeAg loss with detectable HBeAb. Hepatitis B surface antigen (HBsAg) loss is defined as the loss of detectable serum HBsAg in a pt. who was HBsAg +ve at BL. HBsAg seroconversion is defined as HBsAg loss with detectable HBsAb.'}, {'measure': 'Proportion of Participants With Treatment-emergent HBV Resistance Mutations Associated With Virologic Breakthrough', 'timeFrame': 'Week 96', 'description': 'The study was not completed as planned and was terminated early with agreement from the European Medicines Agency (EMEA). Patients did not receive 96 weeks of treatment. Therefore, the primary objective of evaluating virologic breakthrough by Week 96 could not be assessed. Consequently, all protocol-specified inferential analyses on the primary endpoint and all other key secondary efficacy endpoints could not be performed.'}]}, 'conditionsModule': {'keywords': ['lamivudine resistance', 'Hepatitis B virus'], 'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration \\[FDA\\] for the treatment of hepatitis B virus \\[HBV\\]) versus adefovir dipivoxil used alone. The results for patients taking the combination therapy will be compared to the results for patients taking adefovir alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented compensated chronic hepatitis B defined by a clinical history compatible with chronic hepatitis B.\n* Previous or current lamivudine treatment\n* HBV DNA \\> 6 log10 copies/mL\n* Evidence of viral breakthrough\n\nOther protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Patient is pregnant or breastfeeding.\n* Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.\n* Patient has received any anti-HBV treatment for HBV infection other than lamivudine in the 12 months before Screening for this study.\n\nOther protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00376259', 'briefTitle': 'Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-label, Multicenter, Randomized Study of Combination Therapy With Oral LDT600 (Telbivudine) Plus Adefovir Dipivoxil Versus Adefovir Dipivoxil Alone in HBeAg-positive Patients With Chronic Hepatitis B Who Are Lamivudine Resistant', 'orgStudyIdInfo': {'id': 'CLDT600A2304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination therapy', 'description': 'Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.', 'interventionNames': ['Drug: telbivudine', 'Drug: adefovir dipivoxil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adefovir monotherapy', 'description': 'Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.', 'interventionNames': ['Drug: adefovir dipivoxil']}], 'interventions': [{'name': 'telbivudine', 'type': 'DRUG', 'description': '600mg/day oral tablet for 96 weeks', 'armGroupLabels': ['Combination therapy']}, {'name': 'adefovir dipivoxil', 'type': 'DRUG', 'description': '10 mg of adefovir by mouth once daily', 'armGroupLabels': ['Adefovir monotherapy', 'Combination therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Novartis', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'city': 'Pok Fu Lam', 'country': 'Hong Kong', 'geoPoint': {'lat': 22.26861, 'lon': 114.12924}}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Kaohsuing', 'country': 'Taiwan', 'facility': 'Novarits'}, {'city': 'Bangkok', 'country': 'Thailand', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Novartis', 'oldOrganization': 'Novartis'}}}}