UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041053 |
|---|---|
| Receipt number | R000046879 |
| Scientific Title | Therapeutic serum and pulmonary concentration monitoring of clofazimine |
| Date of disclosure of the study information | 2020/07/10 |
| Last modified on | 2024/07/18 16:56:56 |
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Basic information
Public title
Therapeutic serum concentration monitoring for nontuberculous mycobacteria patients
Acronym
Therapeutic serum concentration monitoring for nontuberculous mycobacteria patients
Scientific Title
Therapeutic serum and pulmonary concentration monitoring of clofazimine
Scientific Title:Acronym
Therapeutic serum and pulmonary concentration monitoring of clofazimine
Region
| Japan |
Condition
Condition
Pulmonary nontuberculous mycobacteriosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate relationship between serum and pulmonary clofazimine concentration and efficacy, and adverse drug reactions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurence of adverse effects, including pigmentation and QTc interval prolongation
Key secondary outcomes
Culture negative conversion rate, serum drug concentration, pulmonary drug concentration, drug intake time and blood sampling time, physical findings, clinical laboratory test data, medical histories, comorbidities, concomitant medications
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with pulmonary nontuberculous mycobacteria who are admitted to Fukujuji hospital or outpatient treatment
2)Subjects who have the consent ability
3)Subjects who are taking clofazimine newly or who are already taking clofazimine when participating in the study
Key exclusion criteria
1)Subjects who are pregnant or breastfeeding
2)Subjects whose treatment start date are unknown
3)Subjects who are judged as inadequate by physicians
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | kazuhiko |
| Middle name | |
| Last name | hanada |
Organization
Meiji Pharmaceutical University
Division name
Department of Pharmacometrics and Pharmacokinetics
Zip code
204-8588
Address
2-522-1 Noshio, Kiyose, Tokyo, Japan
TEL
0424958869
hanada@my-pharm.ac.jp
Public contact
Name of contact person
| 1st name | kazuhiko |
| Middle name | |
| Last name | hanada |
Organization
Meiji Pharmaceutical University
Division name
Department of Pharmacometrics and Pharmacokinetics
Zip code
204-8588
Address
2-522-1 Noshio, Kiyose, Tokyo, Japan
TEL
0424958869
Homepage URL
hanada@my-pharm.ac.jp
Sponsor or person
Institute
Meiji Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukujuji Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee
Address
2-522-1 Noshio, Kiyose, Tokyo, Japan
Tel
042-495-8611
kenkyu-r@my-pharm.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20005
Org. issuing International ID_1
Fukujuji Hospital
Study ID_2
20046
Org. issuing International ID_2
Fukujuji Hospital
IND to MHLW
Institutions
Institutions
複十字病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
DOI: 10.1128/aac.00441-22, and 10.1016/j.rmed.2024.107718
Number of participants that the trial has enrolled
73
Results
1. 73 patients were enrolled.
The primary endpoint were determined in 71 patients (2 patients lost to follow-up).
The inclusion has been completed.
2. Number of measurements
71
3. Survey results
Quantitative determination of all samples have been completed..
4. Others
Pharmacokinetic analysis has been completed.
Results date posted
| 2024 | Year | 01 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 07 | Month | 07 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Monitor the side effects regularly
Management information
Registered date
| 2020 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046879
