CompletedNot Applicable

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

South Korea149 participantsStarted 2017-05-25

Plain-language summary

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

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. 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.

Dose of Deltyba

Timeframe: for 24 weeks

Administration duration of Deltyba

Timeframe: for 24 weeks

Compliance of Deltyba

Timeframe: for 24 weeks

NCT IDNCT03470233

SponsorKorea Otsuka Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-06-21