UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030865 |
|---|---|
| Receipt number | 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 20:41:20 |
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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
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
tnomura_@_kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035238
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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