UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of anti-IgE antibody therapy in the patients with wheat allergy
Title of the study (Brief title)	Evaluation of anti-IgE antibody therapy in the patients with wheat allergy
Region	Japan

Condition
Condition	Wheat allergy
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the therapeutic efficacy of anti-IgE antibody (Omalizumab) in the patients with wheat allergy, and to establish its treatment methodology.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	To evaluate the sensitization status before and after the therapy using basophil activation test, specific IgE test, and enzyme-linked immunosorbent assay.
Key secondary outcomes	Food challenge test before and after the treatment if available.

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	Subcutaneous injection of 150 mg of Omalizumab (Novartis Pharma, Japan) once every four weeks, 3 times in all.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who had an allergic reaction to wheat within three months, or patients who avoid wheat ingestion because of the high titer of wheat-specific IgE.
Key exclusion criteria	Patients who had been administrated of Omalizumab in history, and patients who receive immunosuppressive drugs.
Target sample size	20

Research contact person
Name of lead principal investigator	Yuko Chinuki
Organization	Shimane University Hospital
Division name	Dermatology
Address	Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL	0853-20-2210
Email	ychinuki@med.shimane-u.ac.jp

Public contact
Name of contact person	Yuko Chinuki
Organization	Shimane University Hospital
Division name	Dermatology
Address	Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL	0853-20-2210
Homepage URL
Email	ychinuki@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Hospital
Institute
Department

Funding Source
Organization	Research Center for Prevention of Lifestyle-Related Disease
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Fujita Health University Tokyo Medical and Dental University Osaka University Hiroshima University Hyogo Prefectural Kakogawa Medical Center National Hospital Organization, Sagamihara National Hospital National Hospital Organization, Fukuoka National Hospital
Name of secondary funｄer(s)	Yuuka Co., Ltd. KATAYAMA CHEMICAL, INC PHOENIX Co., Ltd.

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	島根大学（島根県） 藤田保健衛生大学（愛知県） 東京医科歯科大学（東京都） 大阪大学（大阪府） 広島大学（広島県） 兵庫県立加古川医療センター（兵庫県） 国立病院機構相模原病院（神奈川県） 国立病院機構福岡病院（福岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 09 Day
Anticipated trial start date	2014 Year 06 Month 02 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 06 Month 30 Day

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

Management information
Registered date	2014 Year 06 Month 16 Day
Last modified on	2016 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016606