Clinical trial NCT03470233: Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multi-drug Resistant Tuberculosis
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-19
Enrollment: 149
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Dose of Deltyba
timeFrame: for 24 weeks
measure: Administration duration of Deltyba
timeFrame: for 24 weeks
measure: Compliance of Deltyba
timeFrame: for 24 weeks
Secondary outcomes:
measure: Incidences of AEs
timeFrame: at least 1 month after the final administration or premature discontinuation
measure: Incidences of ADRs
timeFrame: at least 1 month after the final administration or premature discontinuation
measure: Incidences of AEs in special populations
timeFrame: at least 1 month after the final administration or premature discontinuation
measure: Incidences of ADRs in special populations
timeFrame: at least 1 month after the final administration or premature discontinuation
measure: 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
timeFrame: after completing the administration (Week 24) or premature discontinuation of Deltyba
measure: Response rate
timeFrame: at 24 week (at the end of Deltyba administration)
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
References: