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Completed

NCT Number: NCT03470233

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

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

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Key information

Conditions

Multi-drug Resistant Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Tuberculosis Tuberculosis, Multidrug-Resistant

Sex eligibility

All sexes

Study type

Observational

Primary location

Ulsan University Hospital, Ulsan, South Korea

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About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Dose of Deltyba

    Time frame: for 24 weeks

    Mean values

  2. Administration duration of Deltyba

    Time frame: for 24 weeks

    Mean values

  3. Compliance of Deltyba

    Time frame: for 24 weeks

    percentages (%) of subjects who take Deltyba in excess of 80% compared with the amount of Deltyba prescribed by investigators

Secondary outcomes

  1. Incidences of AEs

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

    Numbers (n) of subjects with AEs

  2. Incidences of ADRs

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

    Percentages (%) of subjects with ADRs

  3. Incidences of AEs in special populations

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

    Percentages (%) of subjects with AEs in special populations, such as the elderly, pregnant women, and patients with hepatic or renal disorder

  4. Incidences of ADRs in special populations

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

    Number (n) of subjects with ADRs in special populations, such as the elderly, pregnant women, and patients with hepatic or renal disorder

  5. 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

    Time frame: after completing the administration (Week 24) or premature discontinuation of Deltyba

    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

  6. Response rate

    Time frame: at 24 week (at the end of Deltyba administration)

    Number (n) of treatment responders (sustained converters plus new converters), Numbers (n) of sustained converters, new converters, non-converters, and reverters

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2018
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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