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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045735
Receipt No. R000052211
Scientific Title Research on therapeutic drugs for celiac disease
Date of disclosure of the study information 2021/10/12
Last modified on 2021/10/13

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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 60

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Ishiguro
Organization Chugai Pharmaceutical Co., Ltd.
Division name Pharmaceutical Science Dept.
Zip code 1038324
Address 1-1 Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo
TEL 03-3281-6611
Email 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
Email DQB0001-TR@chugai-pharm.co.jp

Sponsor
Institute Chugai Pharmaceutical Co., Ltd.
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2021 Year 11 Month 01 Day
Last follow-up date
2022 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
2021 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052211

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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