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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000031905 |
Receipt No. | R000036431 |
Scientific Title | Biomarkers predictive for clinical efficacy of anti-interleukin-5 receptor alpha monoclonal antibody in patients with asthma |
Date of disclosure of the study information | 2018/03/26 |
Last modified on | 2021/03/29 |
Basic information | ||
Public title | Biomarkers predictive for clinical efficacy of anti-interleukin-5 receptor alpha monoclonal antibody in patients with asthma | |
Acronym | Biomarkers foranti-interleukin-5 receptor alpha monoclonal antibody | |
Scientific Title | Biomarkers predictive for clinical efficacy of anti-interleukin-5 receptor alpha monoclonal antibody in patients with asthma | |
Scientific Title:Acronym | Biomarkers foranti-interleukin-5 receptor alpha monoclonal antibody | |
Region |
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Condition | ||
Condition | Bronchial asthma | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Biomarkers predictive for clinical efficacy of anti-IL-5 receptor alpha monoclonal antibody in patients with asthma |
Basic objectives2 | Others |
Basic objectives -Others | Biomarkers for clinical efficacy of anti-IL-5 receptor alpha monoclonal antibody in patients with asthma |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Biomarker discovery for clinical efficacy of anti-IL-5 receptor alpha monoclonal antibody |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | -Subject is diagnosed with asthma according to the Japanese Asthma Prevention and Management Guidelines (JGL).
-Participant demonstrates understanding and has provided an appropriately signed and dated informed consent |
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Key exclusion criteria | Exclusion criteria included COPD, interstitial pneumonia, infectious disease, and active cancer. | |||
Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Juntendo University school of medicine | ||||||
Division name | Department of respiratory medicine | ||||||
Zip code | 113-8431 | ||||||
Address | 3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN | ||||||
TEL | 03-5802-1063 | ||||||
nor@juntendo.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Juntendo University school of medicine | ||||||
Division name | Department of respiratory medicine | ||||||
Zip code | 113-8431 | ||||||
Address | 3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN | ||||||
TEL | 03-5802-1063 | ||||||
Homepage URL | |||||||
nor@juntendo.ac.jp |
Sponsor | |
Institute | Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine |
Institute | |
Department |
Funding Source | |
Organization | Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine |
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 | Juntendo University Research Ethics Committee |
Address | 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan |
Tel | 03-3813-3111 |
chiken@juntendo.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 |
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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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | The method of recruitment;
Subjects having any of the inclusion criteria will be recruited from our outpatient clinic at Juntendo University Hospital by October, 2022. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036431 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |