An observational study in Multi-drug Resistant Tuberculosis, sponsored by Korea Otsuka Pharmaceutical Co., Ltd.. Completed at 2 sites in Korea, Republic of. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Korea Otsuka Pharmaceutical Co., Ltd. · Observational
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
Patients who are prescribed Deltyba® per prescribing information (PI) for the purpose of treatment can be included.
The 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.
Therefore, 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).
The number of subjects may vary from one investigator to another.
Exclusion Criteria
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
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
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
Time frame: 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
Time frame: at 24 week (at the end of Deltyba administration)
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Korea Otsuka Pharmaceutical Co., Ltd.