UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018794 |
|---|---|
| Receipt number | R000021080 |
| Scientific Title | A pilot study to examine the effect of adjunctive anti-IgE antibody on improving the efficacy and safety of oral immunotherapy for cow's milk allergy. |
| Date of disclosure of the study information | 2015/08/25 |
| Last modified on | 2019/03/07 13:10:41 |
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Basic information
Public title
A pilot study to examine the effect of adjunctive anti-IgE antibody on improving the efficacy and safety of oral immunotherapy for cow's milk allergy.
Acronym
A pilot study of adjunctive anti-IgE antibody on oral immunotherapy for cow's milk allergy.
Scientific Title
A pilot study to examine the effect of adjunctive anti-IgE antibody on improving the efficacy and safety of oral immunotherapy for cow's milk allergy.
Scientific Title:Acronym
A pilot study of adjunctive anti-IgE antibody on oral immunotherapy for cow's milk allergy.
Region
| Japan |
Condition
Condition
Cow's milk allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of adjunctive anti-IgE antibody on improving the efficacy and safety of oral immunotherapy for cow's milk allergy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To perform oral immunotherapy (OIT) for cow's milk allergy diagnosed by oral challenge test in combination with anti-IgE therapy and to compare frequency and severity of adverse events until reaching the target amount with conventional OIT.
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
| Medicine |
Interventions/Control_1
Oral immunotherapy in combination with ant-IgE therapy.Patients are administered with omalizumab at four-weekly intervals for 20 weeks from enrollment. The appropriate dose of omalizumab is determined according to administration criteria of asthma.
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
| 6 | years-old | <= |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Severe cow's milk allergic patients between 6-20 years diagnosed by oral challenge test within 3 months. Threshold must be less than 3ml.
2)Patients, whose dose of Xolair (omalizumab) according to administration criteria of asthma is less than 150mg/month.
Key exclusion criteria
1)Patients with past history of tracheal tubing or ICU admission due to anaphylaxis to foods.
2)Patients with severe systemic disease (Heart diseases, Inflammatory diseases, uncontrolled baronchial asthma).
3)Patients using beta blocker.
4)Patients with past history of hypersensitivity to omalizumab.
5)Patients who do not agree to participate in this study.
6)Patients whom physician regards inadequate.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuya Tsuge |
Organization
Fujita Health university
Division name
Faculty of medicine, Department of pediatrics.
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
+81-562-93-9251
itsuge@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuya Tsuge |
Organization
Fujita Health university
Division name
Faculty of medicine, Department of pediatrics.
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
+81-562-93-9251
Homepage URL
itsuge@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health university
Faculty of medicine, Department of pediatrics.
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University Hospital
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
Address
Tel
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
| 2015 | Year | 08 | Month | 25 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 25 | Day |
Last modified on
| 2019 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021080
| 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 |
