Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB

Study Overview
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Brief Summary
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Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings.

Detailed Description
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To collect the usage information of Deltyba in actual clinical settings for the management of resistance to Deltyba

Official Title
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Post-marketing Registry to Assess Usage Information, Safety and Effectiveness of Deltyba® Tablets in Korean Patients With Pulmonary Multi-drug Resistant Tuberculosis (MDR-TB)

Conditions
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Multi-drug Resistant Tuberculosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 1. Patients who are prescribed Deltyba® per prescribing information (PI) for the purpose of treatment can be included in the registry. Exclusion Criteria Patients with known hypersensitivity to Delamanid or any excipients of Deltyba® Patients whose serum albumin < 2.8 g/dL Patients taking medicinal products that are strong inducers of CYP3A (e.g. carbamazepine). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of Deltyba | Mean values | for 24 weeks | 
| Administration duration of Deltyba | Mean values | for 24 weeks | 
| Compliance of Deltyba | percentages (%) of subjects who take Deltyba in excess of 80% compared with the amount of Deltyba prescribed by investigators | for 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of AEs | Numbers (n) of subjects with AEs | at least 1 month after the final administration or premature discontinuation | 
| Incidences of ADRs | Percentages (%) of subjects with ADRs | at least 1 month after the final administration or premature discontinuation | 
| Incidences of AEs in special populations | Percentages (%) of subjects with AEs in special populations, such as the elderly, pregnant women, and patients with hepatic or renal disorder | at least 1 month after the final administration or premature discontinuation | 
| Incidences of ADRs in special populations | Number (n) of subjects with ADRs in special populations, such as the elderly, pregnant women, and patients with hepatic or renal disorder | at least 1 month after the final administration or premature discontinuation | 
| 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 | 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 | after completing the administration (Week 24) or premature discontinuation of Deltyba | 
| Response rate | Number (n) of treatment responders (sustained converters plus new converters), Numbers (n) of sustained converters, new converters, non-converters, and reverters | at 24 week (at the end of Deltyba administration) |