UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012601 |
|---|---|
| Receipt number | R000014735 |
| Scientific Title | High dose intravenous immunoglobulin for the treatment of autoimmune bullous diseases. |
| Date of disclosure of the study information | 2013/12/20 |
| Last modified on | 2022/06/23 09:02:17 |
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Basic information
Public title
High dose intravenous immunoglobulin for the treatment of autoimmune bullous diseases.
Acronym
High dose intravenous immunoglobulin for the treatment of autoimmune bullous diseases.
Scientific Title
High dose intravenous immunoglobulin for the treatment of autoimmune bullous diseases.
Scientific Title:Acronym
High dose intravenous immunoglobulin for the treatment of autoimmune bullous diseases.
Region
| Japan |
Condition
Condition
autoimmune bullous diseases
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Proving the effectiveness of high dose intravenous immunoglobulin therapy for autoimmune bullous disease, our object it the expansion of indications to severe bullosa patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pemphigus Disease Area Index: PDAI
Pemphigus Score
Key secondary outcomes
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
Nihon-Pharmaceutical Co., Ltd.
Kenketsu globenin-I for I.V. injection 400mg/kg/day x 5days
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed as autoimmune bullous disease not pemphigus vulgaris.
Patients who did not improve with the existing treatment.
Patients with severe infections or secondary effect.
Severe case.
Key exclusion criteria
Patients of 5 years from the history of malignancy.
Patients who have treated with steroid or immunosuppressant in 14 days.
Patients with high-risk history of thrombosis, embolism.
Patients who have treated with high dose intravenous immunoglobulin in 6 months.
Patients who have history of secondary effect of blood products.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | HIRASAWA |
Organization
Juntendo University School of Medicine
Division name
Department of Dermatology
Zip code
1130033
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
hirasawa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | HIRASAWA |
Organization
Juntendo University School of Medicine
Division name
Department of Dermatology
Zip code
1130033
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
hirasawa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Juntendo Hospital Ethics Committee
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
chiken@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 16 | Day |
Last modified on
| 2022 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014735
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
