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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030865
Receipt No. R000035238
Scientific Title Intervention study of autoimmune bullous disease with imatinib
Date of disclosure of the study information 2018/01/17
Last modified on 2018/04/05

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Basic information
Public title Intervention study of autoimmune bullous disease with imatinib
Acronym Treatment of autoimmune bullous disease with imatinib
Scientific Title Intervention study of autoimmune bullous disease with imatinib
Scientific Title:Acronym Treatment of autoimmune bullous disease with imatinib
Region
Japan

Condition
Condition Autoimmune bullous disease
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study will demonstrate that imatinib's extravascular antibody transfer inhibitory action improves symptomatic improvement of autoimmune bullous disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of severity of autoimmune bullous disease
Key secondary outcomes Changes in autoantibody titer in blood
Changes in antibody titer in body fluid (saliva, content of blisters)

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 After diagnosis of pemphigus group or pemphigoid group, oral administration of prednisolone is started according to the following:
#1. In case of the initial onset: 0.5 mg/kg/day
#2. In case of recurrence/relapse, keep the preceding dose.
Within 14 days of starting steroid therapy (when the hospital bed is secured), imatinib 400 mg twice daily after dinner and breakfast.
Terminate imatinib at day 7.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria #1 Diagnosed as pemphigus group or pemphigus group.
#2 Those not planning treatment with steroid pulse therapy or IVIG therapy.
#3 The age at the time of consent acquisition is over 20 years old.
#4 The latest blood test and liver function test within 4 weeks before registration satisfy all of the following.
Number of neutrophils >= 1,500 / mm3
Platelet count >= 75,000 / mm3
AST (GOT) <120 IU / L
ALT (GPT) <120 IU / L
Total bilirubin <1.8 mg / dL
5) In the case of men, those agreeing to contrace up to 4 weeks after the start of the study drug administration from the date of final administration of the test drug. In the case of women, one after surgical contraceptive surgery such as postmenopausal (more than 1 year since the last menstruation), or bilateral oophorectomy.
6) With regard to participation in this study, written informed consent has been obtained from the patient himself.
Key exclusion criteria 1) There is a history that has allergy to Imatinib.
2) It has one of the following complications.
Serious heart disease or its past liver disorder, renal disorder
3) Consent Acknowledging participation in other exams within 4 weeks before acquisition.
4) In addition, patients judged unsuitable for the trial responsible doctor or shared medical doctor to safely carry out this study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Kabashima
Organization Kyoto University Hospital
Division name Department of Dermatology
Zip code
Address 54 Shogoin-Kawahara-cho, Sakyoku, Kyoto
TEL 075-751-3310
Email kaba_@_kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nomura
Organization Kyoto University Hospital
Division name Department of Dermatology
Zip code
Address 54 Shogoin-Kawahara-cho, Sakyoku, Kyoto
TEL 075-751-3310
Homepage URL
Email tnomura_@_kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 01 Month 17 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
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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 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
2018 Year 01 Month 17 Day
Last modified on
2018 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035238

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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