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

NCT ID: NCT03470233

Last Updated: 2021-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-25

Study Completion Date

2021-06-21

Brief Summary

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

Detailed Description

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

Conditions

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Multi-drug Resistant Tuberculosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ulsan University Hospital

Ulsan, , South Korea

Site Status

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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242-402-00005

Identifier Type: -

Identifier Source: org_study_id

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