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

Completed

• Conditions: Multi-drug Resistant Tuberculosis

• Registration Number: NCT03470233
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

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

Study Timeline

• Study Start: 2017-05-25
• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-19
• Primary Completion: 2021-06-21
• Study Completion: 2021-06-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose of Deltyba	for 24 weeks	Mean values
Administration duration of Deltyba	for 24 weeks	Mean values
Compliance of Deltyba	for 24 weeks	percentages (%) of subjects who take Deltyba in excess of 80% compared with the amount of Deltyba prescribed by investigators

Secondary Outcome Measures

Name	Time	Method
Response rate	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
Incidences of ADRs	at least 1 month after the final administration or premature discontinuation	Percentages (%) of subjects with ADRs
Incidences of AEs	at least 1 month after the final administration or premature discontinuation	Numbers (n) of subjects with AEs
Incidences of AEs in special populations	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
Incidences of ADRs in special populations	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
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	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

Trial Locations

Locations (2)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of