UMIN-CTR Clinical Trial

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
Email	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
Email	hirasawa@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014735