Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-02-25 @ 5:58 PM
Study NCT ID:
NCT03470233
Status:
COMPLETED
Last Update Posted:
2021-09-17
First Post:
2018-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-04-07', 'releaseDate': '2022-06-23'}], 'estimatedResultsFirstSubmitDate': '2022-06-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018088', 'term': 'Tuberculosis, Multidrug-Resistant'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-16', 'studyFirstSubmitDate': '2018-02-06', 'studyFirstSubmitQcDate': '2018-03-12', 'lastUpdatePostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose of Deltyba', 'timeFrame': 'for 24 weeks', 'description': 'Mean values'}, {'measure': 'Administration duration of Deltyba', 'timeFrame': 'for 24 weeks', 'description': 'Mean values'}, {'measure': 'Compliance of Deltyba', 'timeFrame': 'for 24 weeks', 'description': 'percentages (%) of subjects who take Deltyba in excess of 80% compared with the amount of Deltyba prescribed by investigators'}], 'secondaryOutcomes': [{'measure': 'Incidences of AEs', 'timeFrame': 'at least 1 month after the final administration or premature discontinuation', 'description': 'Numbers (n) of subjects with AEs'}, {'measure': 'Incidences of ADRs', 'timeFrame': 'at least 1 month after the final administration or premature discontinuation', 'description': 'Percentages (%) of subjects with ADRs'}, {'measure': 'Incidences of AEs in special populations', 'timeFrame': 'at least 1 month after the final administration or premature discontinuation', 'description': 'Percentages (%) of subjects with AEs in special populations, such as the elderly, pregnant women, and patients with hepatic or renal disorder'}, {'measure': 'Incidences of ADRs in special populations', 'timeFrame': 'at least 1 month after the final administration or premature discontinuation', 'description': 'Number (n) of subjects with ADRs in special populations, such as the elderly, pregnant women, and patients with hepatic or renal disorder'}, {'measure': 'Observed cases of resistance to Deltyba after completing the administration (Week 24) or premature discontinuation of Deltyba, Observed cases of resistance to Deltyba after 6 months of administration or discontinuation of administration', 'timeFrame': 'after completing the administration (Week 24) or premature discontinuation of Deltyba', 'description': 'Numbers (n) of subjects who developed drug resistance as determined by drug susceptibility testing (DST) to Deltyba in subjects who resulted in positive in sputum test after termination of the administration or were reverter during the course of treatment'}, {'measure': 'Response rate', 'timeFrame': 'at 24 week (at the end of Deltyba administration)', 'description': 'Number (n) of treatment responders (sustained converters plus new converters), Numbers (n) of sustained converters, new converters, non-converters, and reverters'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multi-drug Resistant Tuberculosis']}, 'descriptionModule': {'briefSummary': 'Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings.', 'detailedDescription': 'To collect the usage information of Deltyba in actual clinical settings for the management of resistance to Deltyba'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are prescribed Deltyba® per prescribing information (PI) for the purpose of treatment can be included.\n\nThe expected number of patients during the enrollment period is 248 patients based on the number of patients who might be taking Deltyba, which was estimated considering annual mean change rate from 2009 to 2014 and the rate of patients who had no resistance to pulmonary MDR-TB therapies2, 3.\n\nTherefore, the target number of subjects is about 150, which is 60 % of the number of patients who are expected to take Deltyba during the registration period (n=248).\n\nThe number of subjects may vary from one investigator to another.', 'eligibilityCriteria': 'Inclusion Criteria\n\n1\\. Patients who are prescribed Deltyba® per prescribing information (PI) for the purpose of treatment can be included in the registry.\n\nExclusion Criteria\n\n1. Patients with known hypersensitivity to Delamanid or any excipients of Deltyba®\n2. Patients whose serum albumin \\< 2.8 g/dL\n3. Patients taking medicinal products that are strong inducers of CYP3A (e.g. carbamazepine).\n4. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.'}, 'identificationModule': {'nctId': 'NCT03470233', 'briefTitle': 'Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB', 'organization': {'class': 'INDUSTRY', 'fullName': 'Korea Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Post-marketing Registry to Assess Usage Information, Safety and Effectiveness of Deltyba® Tablets in Korean Patients With Pulmonary Multi-drug Resistant Tuberculosis (MDR-TB)', 'orgStudyIdInfo': {'id': '242-402-00005'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}, {'city': 'Yangsan', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-06-23', 'type': 'RELEASE'}, {'date': '2023-04-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Korea Otsuka Pharmaceutical Co., Ltd.'}}}}