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

Korea Otsuka Pharmaceutical Co., Ltd.149 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

149

Conditions

Multi-drug Resistant Tuberculosis

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 1. Patients with known hypersensitivity to Delamanid or any excipients of Deltyba® 2. Patients whose serum albumin \< 2.8 g/dL 3. Patients taking medicinal products that are strong inducers of CYP3A (e.g. carbamazepine). 4. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.

Locations (2)

Ulsan University Hospital

Ulsan, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea

Outcomes

Primary Outcomes

Dose of Deltyba

Mean values

Time frame: for 24 weeks

Administration duration of Deltyba

Mean values

Time frame: 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

Time frame: for 24 weeks

Secondary Outcomes

Incidences of AEs

Numbers (n) of subjects with AEs

Time frame: at least 1 month after the final administration or premature discontinuation

Incidences of ADRs

Percentages (%) of subjects with ADRs

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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