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Recruitment status Completed
Unique ID issued by UMIN UMIN000011354
Receipt No. R000013306
Scientific Title Anti-IgE Therapy for Kimura's Disease
Date of disclosure of the study information 2013/08/02
Last modified on 2013/08/02

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Basic information
Public title Anti-IgE Therapy for Kimura's Disease
Acronym Anti-IgE Therapy for Kimura's Disease
Scientific Title Anti-IgE Therapy for Kimura's Disease
Scientific Title:Acronym Anti-IgE Therapy for Kimura's Disease
Region
Japan

Condition
Condition Kimura's Disease
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of anti-IgE therapy for Kimura's disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Changes of mass lesion
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 a fixed schedule of eight cycles of omalizumab 300 mg, administered subcutaneously at intervals of 2 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. patients aged >20 years old
2. patients who are unresponsive to standard therapies
3. Levels of serum IgE >30
4. patients agreed to prior written informed consent
Key exclusion criteria 1. patients who are hypersinsitive to omalizumab
2. pregnenat or breast feeding patients
3. patients who are considered inadequate
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Yoshihara
Organization Tokyo Women's Medical University
Division name Department of Otorhinolaryngology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Eri Sakitani
Organization Tokyo Women's Medical University
Division name Department of Otorhinolaryngology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Homepage URL
Email

Sponsor
Institute Tokyo Women's Medical University, Department of Otorhinolaryngolog
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 08 Month 02 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2012 Year 06 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 02 Day
Last modified on
2013 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013306


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