Status:
COMPLETED
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
Lead Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Multi-drug Resistant Tuberculosis
Eligibility:
All Genders
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
- 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
- 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.
Exclusion
Key Trial Info
Start Date :
May 25 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 21 2021
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT03470233
Start Date
May 25 2017
End Date
June 21 2021
Last Update
September 17 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Ulsan University Hospital
Ulsan, South Korea
2
Pusan National University Yangsan Hospital
Yangsan, South Korea