Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT03426618
Status:
COMPLETED
Last Update Posted:
2019-06-03
First Post:
2018-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-31', 'studyFirstSubmitDate': '2018-02-02', 'studyFirstSubmitQcDate': '2018-02-02', 'lastUpdatePostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events (AEs)', 'timeFrame': 'Up to 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Participants who achieved a virologic response', 'timeFrame': 'Up to 48 weeks', 'description': 'Measured by reduction in hepatitis B virus DNA to \\<300 copies/mL'}, {'measure': 'Mean log reduction in hepititis B virus DNA', 'timeFrame': 'Baseline to Weeks 12, 24, and 48'}, {'measure': 'Liver stiffness', 'timeFrame': 'Baseline and Week 48 of treatment'}, {'measure': 'Number of participants with resistance to Baraclude', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Number of participants with virologic relapse in participants', 'timeFrame': 'Up to 48 weeks', 'description': 'Viral load of less than or equal to 300 copies/mL'}, {'measure': 'Number of participants with virologic Relapse in participants', 'timeFrame': 'Up to 48 weeks', 'description': 'Viral load greater than 10,000 copies/mL'}, {'measure': 'Number of participants who were HBeAg seroconverted at Week 48', 'timeFrame': 'Week 48'}, {'measure': 'Number of participants who had HBeAg loss at week 48', 'timeFrame': 'Week 48'}, {'measure': 'Number of participants who were HBsAg seroconverted at Week 48', 'timeFrame': 'Week 48'}, {'measure': 'Number of participants who had HBsAg loss at week 48', 'timeFrame': 'Week 48'}, {'measure': 'Number of participants with normalization of serum ALT at week 12', 'timeFrame': 'Baseline to week 12', 'description': 'Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT'}, {'measure': 'Number of participants with normalization of serum ALT at week 24', 'timeFrame': 'Baseline to week 24', 'description': 'Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT'}, {'measure': 'Number of participants with normalization of serum ALT at week 48', 'timeFrame': 'Baseline to week 48', 'description': 'Normalization is measured as less than or equal to 1 X the upper limit of normal of serum ALT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis B']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'This is a local, prospective observational study (regulatory post marketing surveillance) to access the safety and effectiveness of Baraclude in Korean pediatric patients with chronic HBV infection who are between the ages of 2 and less than 16 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be enrolled with chronic hepatitis B virus (CHB)between the ages of 2 and less than 16 years and who will begin treatment with Baraclude.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* 2 to \\< 16 years of age\n* Patients with chronic hepatitis B infection, eligible for treatment with Baraclude as indicated in the locally approved prescribing information\n\nExclusion Criteria:\n\n* Off-label use of the approved label in Baraclude pediatric indication\n* Patients with a contraindication for the use of Baraclude as described in the locally approved prescribing information\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03426618', 'briefTitle': 'A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Real-World Observational Study for the Safety and Efficacy of Baraclude (Entecavir) in Korean Pediatric (Aged 2-16 Years) Patients With Chronic Hepatitis B', 'orgStudyIdInfo': {'id': 'AI463-514'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric participants with Hepatitis B Virus (HBV)', 'description': 'All participants who received at least 1 dose of Baraclude.', 'interventionNames': ['Other: Non-interventional']}], 'interventions': [{'name': 'Non-interventional', 'type': 'OTHER', 'description': 'Non-interventional', 'armGroupLabels': ['Pediatric participants with Hepatitis B Virus (HBV)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}