An observational study in Multi-drug Resistant Tuberculosis, sponsored by Korea Otsuka Pharmaceutical Co., Ltd.. Completed at 2 sites in Korea, Republic of. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Korea Otsuka Pharmaceutical Co., Ltd. (part of Otsuka Holdings Co., Ltd.) · Observational
Among 11 studies in Tuberculosis, Multidrug-Resistant with a site in Korea, Republic of — 1 open to participants now, 1 under way, 1 of them phase 3. Tuberculosis, Multidrug-Resistant · Korea, Republic of.
Among the 11 studies in Tuberculosis, Multidrug-Resistant with a site in Korea, Republic of, this one is the only one that started in 2017, is one of 2 observational ones, and was the 9th registered.
132 studies on the registry are indexed under Tuberculosis, Multidrug-Resistant; 25 are open to participants now.
Browse Tuberculosis, Multidrug-Resistant studies →1 of the 11 studies in Tuberculosis, Multidrug-Resistant with a site in Korea, Republic of is open now. Recruiting first, the newest first:
Otsuka Pharmaceutical Development & Commercialization, Inc. · Sites in Korea, Republic of, China, Georgia and 7 more countries
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 20 Tuberculosis, Multidrug-Resistant studies recruiting now, 12 (60%) set no upper age limit and 7 (35%) stop at 75 or younger; 9 take children under 18; 2 take healthy volunteers.
This study: all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2017.
This study's enrollment of 149 is below the median of 410 across 42 observational studies indexed under Tuberculosis, Multidrug-Resistant.
Median enrollment 213 across the 9 interventional studies, 325 across the 2 observational. Of the 9 that completed or were terminated, 6 (67%) have results posted.
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6 of 11 have an industry lead sponsor. The 6 most frequent:
Korea Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 42 studies on the registry; 3 are open to participants now.
Korea Otsuka Pharmaceutical Co., Ltd. has 2 studies filed under Tuberculosis, Multidrug-Resistant — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Tuberculosis, Multidrug-Resistant with a site in Korea, Republic of, from their registry updates:
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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.
To collect the usage information of Deltyba in actual clinical settings for the management of resistance to Deltyba
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose of Deltyba
Mean values
Time frame: for 24 weeks
Administration duration of Deltyba
Mean values
Time frame: 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
Time frame: for 24 weeks
Incidences of AEs
Numbers (n) of subjects with AEs
Time frame: at least 1 month after the final administration or premature discontinuation
Incidences of ADRs
Percentages (%) of subjects with ADRs
Time frame: 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
Time frame: 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
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
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
Time frame: 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
Time frame: at 24 week (at the end of Deltyba administration)
Ran from May 2017 to primary completion in Jun 2021, 48 months.
Of 19 observational studies under Tuberculosis, Multidrug-Resistant, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 90. This study's 48 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Tuberculosis, Multidrug-Resistant →
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