UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049566 |
|---|---|
| Receipt number | R000056448 |
| Scientific Title | Prospective Study to Identify Efficacy, Safety, and Predictors of Tezepelumab in Severe Asthma |
| Date of disclosure of the study information | 2022/11/20 |
| Last modified on | 2022/11/20 21:26:58 |
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Basic information
Public title
Prospective Study to Identify Efficacy, Safety, and Predictors of Tezepelumab in Severe Asthma
Acronym
J-EAST
Scientific Title
Prospective Study to Identify Efficacy, Safety, and Predictors of Tezepelumab in Severe Asthma
Scientific Title:Acronym
J-EAST
Region
| Japan |
Condition
Condition
asthma, bronchial asthma
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy, safety, and predictors of efficacy of tezepelumab in severe asthma in a real-world clinical setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predictors of efficacy before treatment and improvement in symptoms after 16 weeks
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) Patients diagnosed with severe asthma according to the Comprehensive Allergy Guidelines 2022
2) Patients with severe bronchial asthma who are using high-dose inhaled steroids and long-acting beta2-stimulants
3) Patients who give written consent to participate in this study
4) Patients 20 years of age or older
Key exclusion criteria
1) Patients with a history of previous administration of tezepelumab
(2) Patients with serious complications such as cardiac, hepatic, or renal disease
(3) Patients who are judged to be inappropriate for the subject by the physician's judgment.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Izumo |
Organization
Japanese Red Cross Medical Center
Division name
Respiratory Medicine
Zip code
150-8935
Address
4-1-22, Hiroo Shibuya-ku, Tokyo
TEL
03-3400-1311
izumo_takehiro@med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Izumo |
Organization
Japanese Red Cross Medical Center
Division name
Respiratory Medicine
Zip code
150-8935
Address
4-1-22, Hiroo Shibuya-ku, Tokyo
TEL
03-3400-1311
Homepage URL
drtake1118@gmail.com
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Japanese Red Cross Medical Center
Address
4-1-22, Hiroo Shibuya-ku, Tokyo
Tel
03-3400-1311
drtake1118@nu2.so-net.ne.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
| 2022 | Year | 11 | Month | 20 | 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
| 2022 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2022 | Year | 11 | Month | 20 | Day |
Last modified on
| 2022 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056448
