UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045735 |
|---|---|
| Receipt number | R000052211 |
| Scientific Title | Research on therapeutic drugs for celiac disease |
| Date of disclosure of the study information | 2021/10/12 |
| Last modified on | 2023/04/25 13:53:35 |
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Basic information
Public title
Research on therapeutic drugs for celiac disease
Acronym
Research on therapeutic drugs for celiac disease
Scientific Title
Research on therapeutic drugs for celiac disease
Scientific Title:Acronym
Research on therapeutic drugs for celiac disease
Region
| Australia |
Condition
Condition
celiac disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Evaluating the effectiveness of therapeutic drugs for celiac disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ELISPOT assay
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Gluten challenge
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Signed and understands the informed consent form.
2.Age between 18 to 70 years of age (inclusive) who have signed an informed consent form.
3.Positive for either of the HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02), HLA-DQ8 (HLA-DQA1*03 and DQB1*0302) or HLA-DQ2.2
4.Able and willing to consume up to 4 slices of wheat bread daily for 3 consecutive days, and provide a total of one unit of blood equivalent to a blood donation.
5.Able to read and understand English.
6.Medically diagnosed with CeD on the basis of a biopsy.
7.Followed GFD for at least 3 months.
Key exclusion criteria
1.History of known Immunoglobulin E -mediated reaction to wheat, barley or Rye
2.Unable to provide documentation of duodenal histology that reports villous atrophy, and of elevated serum transglutaminase-specific IgA, IgA endomysial immunofluorescence (EMA), or for IgA deficient individuals then DGP IgG.
3.Medication within 3 months that might suppress cellular immunity (e.g. oral or parental corticosteroids, immunosuppressive medication)
4.Any medical condition that in the opinion of the investigator may interfere with study conduct.
5.Any medical condition that in the opinion of the investigator would impact the immune response, confound interpretation of study results, or pose an increased risk to the patient.
6.Haemoglobin level or platelet count at screening that is outside the normal gender-specific and age-specific range
7.Individual has uncontrolled medical conditions that in the opinion of the investigator, would increase the risk of blood collection to the patient. For guidance see American Red Cross Blood Donation eligibility criteria
8.Blood donation (one unit of blood) within the previous 8 weeks.
9.Heart disease with heart related symptoms.
10.Heart murmur, or heart valve disorder that has not been medically evaluated, or has caused symptoms within the last 6 months, and is associated with restrictions on normal daily activities.
11.Any medical condition or therapy resulting in impaired blood clotting and bleeding.
12.Body weight less than 50 kg.
13.The pregnant.
14.Vital signs outside the range: systolic blood pressure 90 to 180 mm Hg, diastolic blood pressure 60 to 100 mm Hg, pulse rate regular and 50 to 100 per minute, or body temperature exceeding 99.5oF.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Shinta |
| Middle name | |
| Last name | Kobayashi |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Project Planning & Coordination Dept.
Zip code
1038324
Address
1-1 Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo
TEL
03-3281-6611
DQB0001-TR@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Murakami |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Early Clinical Development Dept.
Zip code
1038324
Address
1-1 Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo
TEL
03-3281-6611
Homepage URL
DQB0001-TR@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
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
The Royal Melbourne Hospital
Address
Level 2 South West 300 Grattan Street Parkville VIC 3050 Australia
Tel
+61393428530
research@mh.org.au
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 | 10 | Month | 12 | 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
| 2021 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052211
