UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Ikuya Tsuge
Organization	Fujita Health university
Division name	Faculty of medicine, Department of pediatrics.
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL	+81-562-93-9251
Email	itsuge@fujita-hu.ac.jp

Public contact
Name of contact person	Ikuya Tsuge
Organization	Fujita Health university
Division name	Faculty of medicine, Department of pediatrics.
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL	+81-562-93-9251
Homepage URL
Email	itsuge@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health university Faculty of medicine, Department of pediatrics.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021080