Multi-drug Resistant TuberculosisNCT03470233
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
An observational study of Multi-drug Resistant Tuberculosis, run by Korea Otsuka Pharmaceutical Co., Ltd. at 2 sites in South Korea.
Trial summary
Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multi-drug Resistant Tuberculosis
- How many people
- 149 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 25 May 2017to 21 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 1. Patients who are prescribed Deltyba® per prescribing information (PI) for the purpose of treatment can be included in the registry.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Ulsan University Hospital
Ulsan
Pusan National University Yangsan Hospital
Yangsan
About this study
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)
Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings.
Read the detailed description
To collect the usage information of Deltyba in actual clinical settings for the management of resistance to Deltyba
- Conditions
- Multi-drug Resistant Tuberculosis
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of Deltyba
Mean values
Measured: for 24 weeks
Administration duration of Deltyba
Mean values
Measured: 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
Measured: for 24 weeks
Secondary outcomes (6)
Incidences of AEs
Numbers (n) of subjects with AEs
Measured: at least 1 month after the final administration or premature discontinuation
Incidences of ADRs
Percentages (%) of subjects with ADRs
Measured: at least 1 month after the final administration or premature discontinuation
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
Measured: at least 1 month after the final administration or premature discontinuation
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
Measured: 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
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
Measured: after completing the administration (Week 24) or premature discontinuation of Deltyba
Response rate
Number (n) of treatment responders (sustained converters plus new converters), Numbers (n) of sustained converters, new converters, non-converters, and reverters
Measured: at 24 week (at the end of Deltyba administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start25 May 2017
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-drug Resistant TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470233
- Sponsor's protocol ID
- 242-402-00005
- Status last verified
- Aug 2021
- First submitted
- 6 Feb 2018
- Last updated
- 17 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03470233
- Acronym / sponsor ID
- 242-402-00005
- Conditions
- Multi-drug Resistant Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 May 2017 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1. Patients who are prescribed Deltyba® per prescribing information (PI) for the purpose of treatment can be included in the registry.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dose of Deltyba
Time frame: for 24 weeks
Mean values
Administration duration of Deltyba
Time frame: for 24 weeks
Mean values
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
6 secondary outcomes
Incidences of AEs
Time frame: 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
Incidences of AEs in special populations
Time frame: 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
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
Response rate
Time frame: at 24 week (at the end of Deltyba administration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multi-drug Resistant Tuberculosis, run by Korea Otsuka Pharmaceutical Co., Ltd. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of Deltyba (time frame: for 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.