UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051506 |
|---|---|
| Receipt number | R000058758 |
| Scientific Title | Special drug use results surveillance for the use of SIRTURO |
| Date of disclosure of the study information | 2023/07/03 |
| Last modified on | 2023/07/03 10:19:11 |
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Basic information
Public title
Special drug use results surveillance for the use of SIRTURO
Acronym
SIR1L
Scientific Title
Special drug use results surveillance for the use of SIRTURO
Scientific Title:Acronym
SIR1L
Region
| Japan |
Condition
Condition
multidrug-resistant pulmonary tuberculosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and effectiveness of SIRTURO Tablets 100 mg (hereinafter, "SIRTURO") in long time use under actual use conditions in patients with multidrug-resistant pulmonary tuberculosis. In addition, Follow-up will be conducted even after the end of the observation period to confirm the outcome of patients up to 120 weeks after the first dosing of SIRTURO.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
[Safety analysis]
(a) Onset status of adverse drug reactions including infectious events
(b) Onset status of serious adverse events
(c) Influencing factors (list of onset status of adverse drug reactions/infections by background factor, etc.)
(d) Onset status of electrocardiogram QT prolongedand Hepatic function disorder .
[Efficacy analysis]
(a) Sputum culture-negative conversion rate
(b) Influencing factors (list of effectiveness by background factor, etc.)
(c) Onset of tolerance mutation
(d) Relapse rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients starting SIRTURO treatment during the registration period
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Manami |
| Middle name | |
| Last name | Kamishima |
Organization
Janssen pharmaceutical K.K
Division name
Safety risk management Dept.
Zip code
101-0065
Address
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
TEL
03-4411-5530
mkamishi@its.jnj.com
Public contact
Name of contact person
| 1st name | Manami |
| Middle name | |
| Last name | Kamishima |
Organization
Janssen pharmaceutical K.K
Division name
Safety risk management Dept.
Zip code
101-0065
Address
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
TEL
03-4411-5530
Homepage URL
mkamishi@its.jnj.com
Sponsor or person
Institute
Janssen pharmaceutical K.K
Institute
Department
Personal name
Funding Source
Organization
Janssen pharmaceutical K.K
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Janssen pharmaceutical K.K
Address
5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo
Tel
03-4411-5530
mkamishi@its.jnj.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the safety and effectiveness of SIRTURO Tablets 100 mg (hereinafter, "SIRTURO") in long time use under actual use conditions in patients with multidrug-resistant pulmonary tuberculosis. In addition, Follow-up will be conducted even after the end of the observation period to confirm the outcome of patients up to 120 weeks after the first dosing of SIRTURO.
Since SIRTURO has been used in only a small number of Japanese patients with multidrug-resistant pulmonary tuberculosis and available information is limited in Japan, this all-patient survey will be conducted to investigate the safety and effectiveness of SIRTURO under actual use conditions in these patients.
Management information
Registered date
| 2023 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058758
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
