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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Autoimmune bullous disease | |
Classification by specialty |
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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 |
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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. |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |