Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-28 @ 12:25 AM
Study NCT ID:
NCT00371150
Status:
COMPLETED
Last Update Posted:
2012-04-16
First Post:
2006-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection
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': 'C413685', 'term': 'entecavir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'BMS Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Entecavir (ETV)', 'description': 'Entecavir tablets, Oral, 0.5 mg, once daily, up to 48 weeks (Includes 6 participants of the Hispanic cohort)', 'otherNumAtRisk': 46, 'otherNumAffected': 21, 'seriousNumAtRisk': 46, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'RENAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'ASCITES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'BLOOD GLUCOSE ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'LEUKOCYTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'LOBAR PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Total', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'comment': 'Since enough participants could not be enrolled in the Hispanic cohort, 95% CI analysis was only performed on the overall population.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '13.0', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '22.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA by PCR Category at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Total', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)'}], 'classes': [{'title': '<50 IU/mL (< 300 copies/mL)', 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000'}, {'value': '69.6', 'groupId': 'OG001'}]}]}, {'title': '50 to <172 IU/mL (300 to < 103 copies/mL)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '172 to <1720 IU/mL (103 to < 104 copies/mL)', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}]}]}, {'title': '1720 to <17200 IU/mL (104 to < 105 copies/mL)', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}, {'title': '≥17,200 IU/mL (≥105 copies/mL)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Total', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through Week 48', 'description': "Virologic rebound is defined as a confirmed increase of ≥ 1 log10 in HBV DNA from the participant's nadir value (2 sequential HBV DNA measurements or last on-treatment measurement)", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. The participants who discontinued prior to Week 48 were counted as failure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Total', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000'}, {'value': '67.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Total', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Total', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated HBeAg-positive participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Total', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '6.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'HBsAg = a part of the hepatitis B virus that, when in the blood, is a marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBsAg Seroconversion at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Total', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'HBsAg = a part of the hepatitis B virus that, when in the blood, is a of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. If a participant was missing the efficacy assessments for a visit, this is considered a failure and was counted as evaluable.'}, {'type': 'SECONDARY', 'title': 'Mean log10 Reduction From Baseline in HBV DNA at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Total', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.1', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'HBV DNA at Week 48', 'categories': [{'measurements': [{'value': '1.88', 'spread': '0.100', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '0.091', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-5.22', 'spread': '0.249', 'groupId': 'OG000'}, {'value': '-5.18', 'spread': '0.231', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, Week 48', 'description': 'HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan AmpliPrep assay. Reduction in log10 HBV count=reduced viral load.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. The participants who discontinued prior to Week 48 were counted as failure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBV DNA < Other IU Cut-off Points That May be Clinically Relevant at the Time of Data Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Total', 'description': 'Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Since there were no other cut-off points other than those at the time of data analysis, this outcome was not analysed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Hispanic', 'description': 'Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG002', 'title': 'Total', 'description': 'Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Discontinuations Due to AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any AE', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 - 4 AEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Grade 2 - 4 Related AEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment through Week 52 + 5 days', 'description': 'AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Total', 'description': 'Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)'}], 'classes': [{'title': 'Hemoglobin-OT', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells-OT', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'White Blood Cells-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils -OT', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils-OF; n=26 , 26', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Platelets-OT', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Platelets-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'International Normalized Ratio-OT', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'International Normalized Ratio-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up', 'description': 'Criteria for hematology abnormalities were graded using the modified WHO grading system. Hemoglobin: \\<=11.0 g/dL; White Blood Cells: \\<4000/mm\\^3; Absolute Neutrophils (includes absolute bands): \\<1500/mm\\^3; Platelets: \\<=99,000/mm\\^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. n = number of participants in the OF period.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Total', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)'}], 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'comment': 'Since enough participants could not be enrolled in the Hispanic cohort, 95% CI analysis was only performed on the overall population.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '69.6', 'groupId': 'OG001', 'lowerLimit': '56.3', 'upperLimit': '82.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48 of ETV treatment', 'description': 'HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA \\< 50 IU/mL = approximately \\<300 copies/mL.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. If a participant is missing the efficacy assessments for a visit, this is considered a failure and is counted as evaluable.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Black / African American', 'description': 'Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'OG001', 'title': 'Total', 'description': 'Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)'}], 'classes': [{'title': 'Alanine aminotransferase-OT', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase-OT', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate aminotransferase-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase-OT', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Albumin-OT', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Albumin-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin-OT', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Total Bilirubin-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Serum Lipase-OT', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Serum Lipase-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine-OT', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen-OT', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Blood Urea Nitrogen-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia-OT', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia-OT', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Hypoglycemia-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia-OT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypernatremia-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia-OT', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hyponatremia-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia-OT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperkalemia-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia-OT', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hypokalemia-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperchloremia-OT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hyperchloremia-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypochloremia-OT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hypochloremia-OF; n=26 , 29', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up', 'description': 'The modified World Health Oranization(WHO)grading system was used to grade the abnormalities. ULN=upper limit of normal. Alanine aminotransferase:\\>1.25xULN, Aspartate aminotransferase:\\>1.25xULN, Alkaline Phosphatase:\\>1.25xULN, Total Bilirubin:\\>1.1xULN, Serum Lipase:\\>1.10xULN, Creatinine:\\>1.1xULN, Blood Urea Nitrogen:1.25xULN, Hyperglycemia:\\>116 mg/dL, Hypoglycemia:\\<64 mg/dL, Hyponatremia:\\<132meq/L, Hypokalemia:\\<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, \\<3 g/dL; Hypernatremia:\\>148 meq/L, Hyperkalemia:\\>5.6 meq/L, Hypokalemia:\\<3.4 meq/L, Hyperchloremia:\\>113 meq/L, Hypochloremia:\\<93 meq/L', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants. n = number of participants in the OF period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Black/ African American', 'description': 'Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'FG001', 'title': 'Hispanic', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Discontinued Prior to Week 48 Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Discontinued at or After Week 48 Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '"Completion of treatment" means received treatment through Week 52', 'groupId': 'FG000', 'numSubjects': '37'}, {'comment': '"Completion of treatment" means received treatment through Week 52', 'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'A total of 131 participants were enrolled at 27 sites.', 'preAssignmentDetails': 'Of the 131 participants enrolled, 85 were never treated (82 no longer met study criteria, 2 withdrew consent, and 1 had other reason).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Black/ African American', 'description': 'Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'BG001', 'title': 'Hispanic', 'description': 'ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.0', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '67'}, {'value': '48.0', 'groupId': 'BG001', 'lowerLimit': '29', 'upperLimit': '69'}, {'value': '40.0', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic / Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic / Latino', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black/ African American', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hepatitis B surface antigen (HBsAg) status at baseline', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hepatitis B e antigen (HBeAg) status at baseline', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hepatitis B e antibody (HBeAb) at baseline', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alanine Aminotransferase (ALT)', 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000', 'lowerLimit': '30', 'upperLimit': '617'}, {'value': '113', 'groupId': 'BG001', 'lowerLimit': '80', 'upperLimit': '301'}, {'value': '107', 'groupId': 'BG002', 'lowerLimit': '30', 'upperLimit': '617'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'FULL_RANGE'}, {'title': 'Albumin', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'BG000', 'lowerLimit': '3.0', 'upperLimit': '5.1'}, {'value': '4.3', 'groupId': 'BG001', 'lowerLimit': '3.5', 'upperLimit': '4.6'}, {'value': '4.3', 'groupId': 'BG002', 'lowerLimit': '3.0', 'upperLimit': '5.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/dL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Total Bilirubin', 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'BG000', 'lowerLimit': '0.3', 'upperLimit': '2.1'}, {'value': '0.5', 'groupId': 'BG001', 'lowerLimit': '0.3', 'upperLimit': '1.1'}, {'value': '0.6', 'groupId': 'BG002', 'lowerLimit': '0.3', 'upperLimit': '2.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-22', 'studyFirstSubmitDate': '2006-08-29', 'resultsFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2006-08-31', 'lastUpdatePostDateStruct': {'date': '2012-04-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-22', 'studyFirstPostDateStruct': {'date': '2006-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) < 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 48', 'timeFrame': 'Week 48 of ETV treatment', 'description': 'HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA \\< 50 IU/mL = approximately \\<300 copies/mL.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieve HBV DNA < Lower Limit of Quantitation (LOQ = 29 IU/mL [Approximately 169 Copies/mL]) at Week 48', 'timeFrame': 'Week 48', 'description': 'HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay. LOQ is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection.'}, {'measure': 'Percentage of Participants With HBV DNA by PCR Category at Week 48', 'timeFrame': 'Week 48', 'description': 'HBV DNA assessments were performed using the Roche COBAS® TaqMan AmpliPrep assay.'}, {'measure': 'Percentage of Participants With Virologic Rebound Through Week 48 While on Continued Dosing With ETV', 'timeFrame': 'through Week 48', 'description': "Virologic rebound is defined as a confirmed increase of ≥ 1 log10 in HBV DNA from the participant's nadir value (2 sequential HBV DNA measurements or last on-treatment measurement)"}, {'measure': 'Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48', 'timeFrame': 'Week 48', 'description': 'ALT normalization=ALT level being less than or equal to 1 times the upper limit of normal (ULN). ULN for ALT is 37 U/L.'}, {'measure': 'Percentage of Participants With Confirmed HBeAg Loss at Week 48 (for HBeAg-positive Participants Only)', 'timeFrame': 'Week 48', 'description': 'HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week'}, {'measure': 'Percentage of Participants With HBeAg Seroconversion at Week 48 (for HBeAg-positive Participants Only)', 'timeFrame': 'Week 48', 'description': 'HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).'}, {'measure': 'Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48', 'timeFrame': 'Week 48', 'description': 'HBsAg = a part of the hepatitis B virus that, when in the blood, is a marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.'}, {'measure': 'Percentage of Participants With HBsAg Seroconversion at Week 48', 'timeFrame': 'Week 48', 'description': 'HBsAg = a part of the hepatitis B virus that, when in the blood, is a of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.'}, {'measure': 'Mean log10 Reduction From Baseline in HBV DNA at Week 48', 'timeFrame': 'baseline, Week 48', 'description': 'HBV DNA was analyzed by PCR, using the Roche COBAS®TaqMan TaqMan AmpliPrep assay. Reduction in log10 HBV count=reduced viral load.'}, {'measure': 'Percentage of Participants With HBV DNA < Other IU Cut-off Points That May be Clinically Relevant at the Time of Data Analysis', 'timeFrame': 'Week 48'}, {'measure': 'Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to Adverse Events', 'timeFrame': 'From enrollment through Week 52 + 5 days', 'description': 'AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded.'}, {'measure': 'Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF): Hematology', 'timeFrame': 'OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up', 'description': 'Criteria for hematology abnormalities were graded using the modified WHO grading system. Hemoglobin: \\<=11.0 g/dL; White Blood Cells: \\<4000/mm\\^3; Absolute Neutrophils (includes absolute bands): \\<1500/mm\\^3; Platelets: \\<=99,000/mm\\^3; International Normalized Ratio: ≥ 1.5 and ≥ 0.5 from baseline.'}, {'measure': 'Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) : Serum Chemistry', 'timeFrame': 'OT: From start of study therapy through Week 52 + 5 days; OF= End of OT period + 24-week follow-up', 'description': 'The modified World Health Oranization(WHO)grading system was used to grade the abnormalities. ULN=upper limit of normal. Alanine aminotransferase:\\>1.25xULN, Aspartate aminotransferase:\\>1.25xULN, Alkaline Phosphatase:\\>1.25xULN, Total Bilirubin:\\>1.1xULN, Serum Lipase:\\>1.10xULN, Creatinine:\\>1.1xULN, Blood Urea Nitrogen:1.25xULN, Hyperglycemia:\\>116 mg/dL, Hypoglycemia:\\<64 mg/dL, Hyponatremia:\\<132meq/L, Hypokalemia:\\<3.4 meq/L, Albumin:≥1g/dL decrease from baseline, \\<3 g/dL; Hypernatremia:\\>148 meq/L, Hyperkalemia:\\>5.6 meq/L, Hypokalemia:\\<3.4 meq/L, Hyperchloremia:\\>113 meq/L, Hypochloremia:\\<93 meq/L'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis B Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to develop observational clinical experience with the use of entecavir in participants who are either of Black/African-American race or of Hispanic ethnicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic HBV infection, with either HBeAg-positive (HBeAb-negative) or HBeAg-negative (HBeAb-positive) disease\n* Black/African American Race and/or Hispanic ethnicity\n* Nucleoside/tide-naive\n* Males or females ≥ 16 years of age (or minimum age required in a given country)\n* Compensated liver function\n* ALT of 1.3 to 10 x upper limit of normal (ULN)\n* No Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV)\n\nExclusion Criteria\n\n* Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 6 weeks after study medication has been discontinued\n* Women who are pregnant or breastfeeding\n* Women with a positive pregnancy test on enrollment or prior to study drug administration\n* Evidence of decompensated cirrhosis including but not limited to: variceal bleeding; hepatic encephalopathy; or ascites requiring management with diuretics or paracentesis\n* Recent history of pancreatitis (resolution of any recent pancreatitis must be documented by normal lipase at least 12 weeks prior to the first dose of study medication)\n* Currently abusing illegal drugs or alcohol sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis\n* Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications\n* Serum creatinine \\> 1.5 mg/dL\n* Hemoglobin \\< 10.0 g/dL\n* Platelet count \\< 70,000/mm3\n* Absolute neutrophil count \\< 1200 cells/mm3\n* Serum alpha fetoprotein (AFP) level \\> 100 ng/mL. If the AFP level is between 21 and 100 ng/mL, it must be repeated. If the repeat AFP level is between 21 and 100 ng/mL and if ultrasonography or computerized tomography (CT) of the liver performed prior to the first dose of study medication does not demonstrate a focal lesion suggestive of carcinoma, the subject may be dosed in the study\n* Known history of allergy to nucleoside analogues\n* Any prior therapy with Entecavir\n* Any prior or concomitant use of nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., ETV, lamivudine (LVD), tenofovir \\[TDF\\], emtricitabine (FTC), clevudine, telbivudine \\[LdT\\], famciclovir), or any other experimental anti-HBV antiviral agent\n* Therapy with interferon, thymosin alpha or other immunostimulators within 24 weeks of enrollment (i.e., dosing) into this study\n* Subjects who require chronic administration of concomitant medications which cause immunosuppression or which are associated with a high rate of nephrotoxicity or hepatotoxicity, or which affect renal excretion, should not be enrolled in this study\n* Unable to tolerate oral medication\n* Poor peripheral venous access\n* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study"}, 'identificationModule': {'nctId': 'NCT00371150', 'briefTitle': 'Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Study to Describe the Antiviral Effect of Entecavir (ETV) in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection Who Are Nucleoside-Naive', 'orgStudyIdInfo': {'id': 'AI463-085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm1', 'interventionNames': ['Drug: Entecavir']}], 'interventions': [{'name': 'Entecavir', 'type': 'DRUG', 'otherNames': ['Baraclude', 'BMS-200475'], 'description': 'Tablets, Oral, 0.5 mg, once daily, up to 52 weeks', 'armGroupLabels': ['Arm1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36116', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Liver & Digestive Specialists (Alds)', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University Of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University Of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Empire International Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University Of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20740', 'city': 'College Park', 'state': 'Maryland', 'country': 'United States', 'facility': 'Banks Hepatology Institute, Pc', 'geoPoint': {'lat': 38.98067, 'lon': -76.93692}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham And Women'S Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'L L C Bda The Research Institute', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Va New York Harbor Healthcare System', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10701', 'city': 'Yonkers', 'state': 'New York', 'country': 'United States', 'facility': 'Westchester Digestive Disease Group, Llp', 'geoPoint': {'lat': 40.9304, 'lon': -73.89789}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Albert Einstein Healthcare Network', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Alamo Medical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hunter Holmes Mcguire D V A M C', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '40110', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Local Institution', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '30150', 'city': 'Belo Horizonte - 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