Unique ID issued by UMIN | UMIN000018794 |
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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 |
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.
A pilot study of adjunctive anti-IgE antibody on oral immunotherapy for cow's milk allergy.
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.
A pilot study of adjunctive anti-IgE antibody on oral immunotherapy for cow's milk allergy.
Japan |
Cow's milk allergy
Pediatrics |
Others
NO
To examine the effect of adjunctive anti-IgE antibody on improving the efficacy and safety of oral immunotherapy for cow's milk allergy.
Safety,Efficacy
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
6 | years-old | <= |
20 | years-old | >= |
Male and Female
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.
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.
5
1st name | |
Middle name | |
Last name | Ikuya Tsuge |
Fujita Health university
Faculty of medicine, Department of pediatrics.
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
+81-562-93-9251
itsuge@fujita-hu.ac.jp
1st name | |
Middle name | |
Last name | Ikuya Tsuge |
Fujita Health university
Faculty of medicine, Department of pediatrics.
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
+81-562-93-9251
itsuge@fujita-hu.ac.jp
Fujita Health university
Faculty of medicine, Department of pediatrics.
Fujita Health University Hospital
Self funding
NO
2015 | Year | 08 | Month | 25 | Day |
Unpublished
Completed
2015 | Year | 06 | Month | 11 | Day |
2015 | Year | 08 | Month | 25 | Day |
2015 | Year | 08 | Month | 25 | Day |
2019 | Year | 03 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021080
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