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

Multi-drug Resistant Tuberculosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470233
• Other study ID #: 242-402-00005
• Status: Completed
• Start date: May 25, 2017
• Est. completion date: June 21, 2021

Study information

• Verified date: August 2021
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Multi-drug Resistant Tuberculosis
• Tuberculosis
• Tuberculosis, Multidrug-Resistant

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose of Deltyba	Mean values	for 24 weeks
Primary	Administration duration of Deltyba	Mean values	for 24 weeks
Primary	Compliance of Deltyba	percentages (%) of subjects who take Deltyba in excess of 80% compared with the amount of Deltyba prescribed by investigators	for 24 weeks
Secondary	Incidences of AEs	Numbers (n) of subjects with AEs	at least 1 month after the final administration or premature discontinuation
Secondary	Incidences of ADRs	Percentages (%) of subjects with ADRs	at least 1 month after the final administration or premature discontinuation
Secondary	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	at least 1 month after the final administration or premature discontinuation
Secondary	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	at least 1 month after the final administration or premature discontinuation
Secondary	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	after completing the administration (Week 24) or premature discontinuation of Deltyba
Secondary	Response rate	Number (n) of treatment responders (sustained converters plus new converters), Numbers (n) of sustained converters, new converters, non-converters, and reverters	at 24 week (at the end of Deltyba administration)