UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041915 |
|---|---|
| Receipt number | R000044359 |
| Scientific Title | Identification of biomarkers that predict responsiveness to Dupilumab among severe asthma |
| Date of disclosure of the study information | 2020/09/28 |
| Last modified on | 2022/06/01 16:11:39 |
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Basic information
Public title
Identification of biomarkers that predict responsiveness to Dupilumab among severe asthma
Acronym
Biomarker for Dupilumab
Scientific Title
Identification of biomarkers that predict responsiveness to Dupilumab among severe asthma
Scientific Title:Acronym
Biomarker for Dupilumab
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identification of biomarkers that predict responsiveness to Dupilumab
Basic objectives2
Others
Basic objectives -Others
Clarify effectiveness of Dupilumab among severe asthma.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationships between a change in GETE and serum cytokine levels
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient with severe asthma
2. Patient going to use Dupilumab
3. Patient using high dose ICS and other control agents
Key exclusion criteria
Patient whom the researchers think is not suitable for the study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
204-8585
Address
3-1-1 Takeoka, Kiyose-Shi, Tokyo, Japan
TEL
042-491-2111
fueta-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
204-8585
Address
3-1-1 Takeoka, Kiyose-Shi, Tokyo, Japan
TEL
042-491-2111
Homepage URL
fueta-tky@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Tokyo National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Tokyo National Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Ethics Review Board of National Hospital Organization Tokyo National Hospital
Address
3-1-1 Takeoka, Kiyose-Shi, Tokyo, Japan
Tel
042-491-2111
tsukahara.rie.tz@mail.hosp.go.jp
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
| 2020 | Year | 09 | Month | 28 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will end at March, 31, 2023.
Management information
Registered date
| 2020 | Year | 09 | Month | 28 | Day |
Last modified on
| 2022 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044359
| 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 |
