UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019250 |
|---|---|
| Receipt number | R000022254 |
| Scientific Title | Evaluation of long-term anti-IgE antibody therapy in the patients with wheat allergy |
| Date of disclosure of the study information | 2015/10/10 |
| Last modified on | 2019/03/27 18:11:06 |
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Basic information
Public title
Evaluation of long-term anti-IgE antibody therapy in the patients with wheat allergy
Acronym
Long-term anti-IgE antibody therapy
Scientific Title
Evaluation of long-term anti-IgE antibody therapy in the patients with wheat allergy
Scientific Title:Acronym
Long-term anti-IgE antibody therapy
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 long-term therapy in the patients with severe wheat allergy, by patient's clinical condition and basophil activation test using peripheral blood.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of reactivity below 10% to wheat allergen in basophil activation test using peripheral blood after the treatment.
Key secondary outcomes
Rate of 0 score in wheat-challenge test after the treatment.
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
1. Generic name: Omalizumab; trade name: Xolair for s.c. ingection 75mg/V or 150mg/V (Novartis Pharma, Japan).
2. Start the treatment protocol within 4 weeks of entry. Administration dose and intervals of Omalizumab are calculated by total IgE and body weight, 75-600mg for 2-4 week interval. Duration of administrations is 44 weeks and follow-up is 24 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. More than 20 years old male and female.
2. Patients who meet the diagnostic criteria of immediate-type wheat allergy induced by GP19S made by Special Committee for Japanese Society for Allergology; Patient who meet the diagnostic criteria of wheat-dependent exercise-induced anaphylaxis made by study group of Guideline for the treatment of life-threatening food allergy, supported by Health and Labor Sciences Research Grant; Patients who had an allergic reaction to wheat within one year or patients who avoid wheat ingestion because of the high titer of serum wheat-specific IgE.
3. Those who can visit doctor's office every 2 to 4 weeks.
4. Those who can sign the treatment consent form.
Key exclusion criteria
1. Patients who have hypersensitivity to ingredients of Omalizumab (Novartis Pharma, Japan).
2. Patients who receive immunosuppressive drugs.
3. Patients with decompensated liver cirrhosis.
4. Patients with severe kidney disease; more than 2.0mg/dL of serum creatinine level within 4 weeks prior to the entry.
5. Patients with liver disease, psychiatric disorder, convulsive seizure and seizure disorder, cardiovascular disease, abnormal hemoglobin disease, hemophilia, and autoimmune disease.
6. Pregnant women, breast-feeding women, and women suspected of being pregnant.
7. Patients ineligible for the clinical trial at a physician's discretion.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Eishin |
| Middle name | |
| Last name | Morita |
Organization
Shimane University Hospital
Division name
Dermatology
Zip code
6938501
Address
Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2210
emorita@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Chinuki |
Organization
Shimane University Hospital
Division name
Dermatology
Zip code
6938501
Address
Enya 89-1, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2210
Homepage URL
http://www.rcplrd.org/clinical_research
ychinuki@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
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
National Hospital Organization, Sagamihara National Hospital
National Hospital Organization, Fukuoka National Hospital
Tokyo Medical and Dental University
Osaka University
Hiroshima University
Hyogo Prefectural Kakogawa Medical Center
Kobe University
Name of secondary funder(s)
Yuuka Co., Ltd
Katayama Kogyo Co., Ltd
PHOENIX Co., Ltd
IRB Contact (For public release)
Organization
Clinical Resarch Center, Shimane University Hospital
Address
89-1, Enya-cyou, Izumo, Shimane
Tel
0853-20-2515
kenkyu@med.shimane-u.ac.jp
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）Shimane University (Shimane)
藤田保健衛生大学（愛知県）Fujita Health University (Aichi)
東京医科歯科大学（東京都）Tokyo Medical and Dental University (Tokyo)
大阪大学（大阪府）Osaka University (Osaka)
広島大学（広島県）Hiroshima University (Hiroshima)
神戸大学（兵庫県）Kobe University (Hyogo)
兵庫県立加古川医療センター（兵庫県）Hyogo Prefectural Kakogawa Medical Center (Hyogo)
国立病院機構相模原病院（神奈川県）National Hospital Organization, Sagamihara National Hospital (Kanagawa)
国立病院機構福岡病院（福岡県）National Hospital Organization, Fukuoka National Hospital (Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 10 | 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
20
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 | 09 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 06 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022254
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