UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of oral immunotherapy combination with omalizumab for severe cow's milk allergy- follow up study-
Title of the study (Brief title)	Oral immunotherapy combination with omalizumab for severe cow's milk allergy- follow up study-
Region	Japan

Condition
Condition	food allergy
Classification by specialty	Clinical immunology Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the efficacy and safety for long period after the randomized study of oral immunotherapy combination with omalizumab for severe cow's milk allergy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The percentages of sustained unresponsiveness at the months 18 after the start of the randomized study of oral immunotherapy combination with omalizumab for severe cow's milk allergy
Key secondary outcomes	The frequencies of allergic reactions from the start to the months 18 after the randomized study of oral immunotherapy combination with omalizumab for severe cow's milk allergy

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Food
Interventions/Control_1	To examine the efficacy and safety for months 18 at the start of the randomized study of oral immunotherapy combination with omalizumab for severe cow's milk allergy
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	15 years-old >
Gender	Male and Female
Key inclusion criteria	1.Children who gain desensitization of cow's milk after the randomized study of oral immunotherapy for severe cow's milk allergy and who continue daily cow's milk ingestion. 2. Children who obtain the informed consent of the study
Key exclusion criteria	1. Children who have acute disease and chronic disease except allergic disease. 2.Children or guardian who deny the study 3. Children who were judged as inappropriate by the study director
Target sample size	15

Research contact person
Name of lead principal investigator	Shoichiro Taniuchi
Organization	Kansai Medical University
Division name	Department of Pediatrics
Address	2-5-1, Shinmachi Hirakata city, Osaka, Japan
TEL	072-804-0101
Email	taniuchi@hirakata.kmu.ac.jp

Public contact
Name of contact person	Shoichiro Taniuchi
Organization	Kansai Medical University
Division name	Department of Pediatrics
Address	2-5-1, Shinmachi Hirakata city, Osaka, Japan
TEL	072-804-0101
Homepage URL
Email	taniuchi@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	Kansai Medical University
Organization
Division
Category of Funding Organization	Other
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	関西医科大学

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry	2018 Year 07 Month 31 Day
Date trial data considered complete	2018 Year 07 Month 31 Day
Date analysis concluded	2018 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 13 Day
Last modified on	2016 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=R000028078