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

September 16, 2021 updated by: Korea Otsuka Pharmaceutical Co., Ltd.

Post-marketing Registry to Assess Usage Information, Safety and Effectiveness of Deltyba® Tablets in Korean Patients With Pulmonary Multi-drug Resistant Tuberculosis (MDR-TB)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital
      • Yangsan, Korea, Republic of
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose of Deltyba
Time Frame: for 24 weeks
Mean values
for 24 weeks
Administration duration of Deltyba
Time Frame: for 24 weeks
Mean values
for 24 weeks
Compliance of Deltyba
Time Frame: for 24 weeks
percentages (%) of subjects who take Deltyba in excess of 80% compared with the amount of Deltyba prescribed by investigators
for 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidences of AEs
Time Frame: at least 1 month after the final administration or premature discontinuation
Numbers (n) of subjects with AEs
at least 1 month after the final administration or premature discontinuation
Incidences of ADRs
Time Frame: at least 1 month after the final administration or premature discontinuation
Percentages (%) of subjects with ADRs
at least 1 month after the final administration or premature discontinuation
Incidences of AEs in special populations
Time Frame: 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
at least 1 month after the final administration or premature discontinuation
Incidences of ADRs in special populations
Time Frame: 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
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
Time Frame: 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
after completing the administration (Week 24) or premature discontinuation of Deltyba
Response rate
Time Frame: 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
at 24 week (at the end of Deltyba administration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korea Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 242-402-00005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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