UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052531 |
|---|---|
| Receipt number | R000059942 |
| Scientific Title | The Impact of PAI-1 Gene Polymorphisms on the Efficacy of Tezepelumab |
| Date of disclosure of the study information | 2023/10/18 |
| Last modified on | 2023/10/18 12:45:49 |
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Basic information
Public title
The Impact of PAI-1 Gene Polymorphisms on the Efficacy of Tezepelumab
Acronym
The Impact of PAI-1 Gene Polymorphisms on the Efficacy of Tezepelumab
Scientific Title
The Impact of PAI-1 Gene Polymorphisms on the Efficacy of Tezepelumab
Scientific Title:Acronym
The Impact of PAI-1 Gene Polymorphisms on the Efficacy of Tezepelumab
Region
| Japan |
Condition
Condition
Bronchial Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to elucidate whether the 4G/5G polymorphism in the promoter region of the PAI-1 gene affects the therapeutic efficacy of Tezepelumab."
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is the annual exacerbation rate from the beginning of treatment to one year later, and the secondary outcomes include the Asthma Control Questionnaire-6, pulmonary function tests (FEV1, PEF), exhaled nitric oxide levels, peripheral blood eosinophil count, and total IgE levels at 84 weeks and one year after treatment initiation.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients must meet all of the following criteria
1) Patients with severe or refractory bronchial asthma whose asthma symptoms cannot be controlled by existing therapy and who will be treated with tezepelumab between the start of the study and November 1, 2024.
2) Patients 18 years of age or older.
Key exclusion criteria
Exclusion criteria
1) Patients treated with bronchial thermoplasty
2) Patients with comorbidities requiring systemic steroids or immunosuppressive agents (except when systemic steroids are used as maintenance therapy for asthma)
3) Patients who are deemed inappropriate as research subjects by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Fukahori |
Organization
Nagasaki University Hospital
Division name
Respiratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
+81958197273
susumu-f@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Fukahori |
Organization
Nagasaki University Hospital
Division name
Respiratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL
+81958197273
Homepage URL
susumu-f@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Allergology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki 852-8501, Japan
Tel
+81958197273
susumu-f@nagasaki-u.ac.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
| 2023 | Year | 10 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059942
| 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 |
