UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043545 |
|---|---|
| Receipt number | R000049729 |
| Scientific Title | Japan prospective multicenter study for the optimization of the COVID-19 vaccination based on the immune response and safety profile in inflammatory bowel disease patients |
| Date of disclosure of the study information | 2021/03/08 |
| Last modified on | 2024/03/31 23:42:06 |
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Basic information
Public title
Japan prospective multicenter study for the optimization of the COVID-19 vaccination based on the immune response and safety profile in inflammatory bowel disease patients
Acronym
J-COMBAT trial
Scientific Title
Japan prospective multicenter study for the optimization of the COVID-19 vaccination based on the immune response and safety profile in inflammatory bowel disease patients
Scientific Title:Acronym
J-COMBAT trial
Region
| Japan |
Condition
Condition
inflammatory bowel disease (ulcerative colitis, Crohn's disease)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of COVID-19 vaccination in patients with inflammatory bowel disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The immune responses and safety profiles of COVID-19 vaccination in patients with inflammatory bowel disease.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with inflammatory bowel disease (600 cases) or healthy persons (150 persons) who are willing vaccination of COVID-19.
Key exclusion criteria
1) The patients with active COVID-19
2) The patients with inflammatory bowel disease or persons who are not vaccinated.
3) The patients with inflammatory bowel disease or persons who are less than 16 years old.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Watanabe |
Organization
Hyogo College of Medicine
Division name
Center for Inflammatory Bowel Disease, Division of Internal Medicine
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6663
kenjiw1779@gmail.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Watanabe |
Organization
Hyogo College of Medicine
Division name
Center for Inflammatory Bowel Disease, Division of Internal Medicine
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6663
Homepage URL
kenjiw1779@gmail.com
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour and Welfare of Japan
The Japanese Society of Gastroenterology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of Hyogo College of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel
0798-45-6066
rinri@hyo-med.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
| 2021 | Year | 03 | Month | 08 | 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
| 2021 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 25 | 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
Prospective multicenter observational study
Subjects: Patients with inflammatory bowel disease at the research institutions, healthy controls related to the research institutions
Recruitment period: After February 25, 2021
Recruitment method: Obtaining a consent form using the patient consent manual and the opt-out
Investigation items:
1) Clinical backgrounds
2) Blood test results
3) Detailed information and adverse events regarding the COVID-19 vaccination
4) Immune responses to COVID-19 vaccination (IgG antibody titer to anti SARS-CoV-2)
5) Detailed information on COVID-19 cases
6) History of allergies and adverse events for previous vaccinations
7) Information on influenza vaccination after COVID-19 vaccination
8) Anti-adenovirus antibody titer in viral vector vaccinated individuals
Management information
Registered date
| 2021 | Year | 03 | Month | 08 | Day |
Last modified on
| 2024 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049729
| 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 |
