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

NCT03470233 | Completed

• 1 other identifier: 242-402-00005
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Multi-drug Resistant Tuberculosis

Outcome Measures

Primary Outcomes (3)

• Dose of Deltyba

  Mean values

  for 24 weeks

• Administration duration of Deltyba

  Mean values

  for 24 weeks

• 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 Outcomes (6)

• Incidences of AEs

  at least 1 month after the final administration or premature discontinuation

• Incidences of ADRs

  at least 1 month after the final administration or premature discontinuation

• Incidences of AEs in special populations

  at least 1 month after the final administration or premature discontinuation

• Incidences of ADRs in special populations

  at least 1 month after the final administration or premature discontinuation

• 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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. Patients who are prescribed Deltyba® per prescribing information (PI) for the purpose of treatment can be included in the registry.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Ulsan University Hospital

Ulsan, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: March 19, 2018
• Study Start: May 25, 2017
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-08

Locations

KR (2)