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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009775
Receipt No. R000011449
Scientific Title Optimal use determination test of GCAP(Granulocyte and Monocyte Adsorption Apheresis):Adacolumn Study on twice a week Adacolumn that target pustular psoriasis
Date of disclosure of the study information 2013/01/20
Last modified on 2013/01/13

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Basic information
Public title Optimal use determination test of GCAP(Granulocyte and Monocyte Adsorption Apheresis):Adacolumn

Study on twice a week Adacolumn that target pustular psoriasis
Acronym Study on twice a week GCAP that target pustular psoriasis
Scientific Title Optimal use determination test of GCAP(Granulocyte and Monocyte Adsorption Apheresis):Adacolumn

Study on twice a week Adacolumn that target pustular psoriasis
Scientific Title:Acronym Study on twice a week GCAP that target pustular psoriasis
Region
Japan

Condition
Condition pustular psoriasis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To pustular psoriasis with one enforcement / insufficient in an effect in a week in insurance application,it carries out in a week in 2 times/,and efficacy and safety are examined.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Scoring of pustular psoriasis severe INDEX.
erythema,pustule,edema,general status(fever,WBC,CRP,serum albmine)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 With the moderate to severe diseases pustular psoriasis
1 - The case in which the conventional cure does not succeed
2 The case which cannot use conventional treatments according to side effects etc.
3 The case considered that early remission introduction is required critical
4 Blood vessel requisite for extracorporeal circulation treatment is securable.
5 Who understands an explanatory matter and approval in document is made
Key exclusion criteria 1)The patient whose granulocyte count is not more than 2,000/mm3.

2)The patient who owns a critical cardiovascular diseases

3)The hypotensive patient of 80 or less mmHg of blood-pressure systolics

4)The patient permitted extreme drying, rise of a solidification system on the strength, critical anemia, and the number fall of blood platelets

5)The patient to whom the advanced or critical adverse experience has appeared by extracorporeal circulation treatment performed in the past

6)The patient whom the physician judged to be unfit as a subject
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sakiko Ohgiya
Organization Juntendo university hospital
Division name Department of dermatology
Zip code
Address 2-1-1 Hongo,Bunkyo-ku,Tokyo,Japan
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sakiko Ohgiya
Organization Juntendo university hospital
Division name Department of dermatology
Zip code
Address 2-1-1 Hongo,Bunkyo-ku,Tokyo,Japan
TEL 03-3813-3111
Homepage URL http://www.juntendo.ac.jp/hospital/clinic_c/gcp/index.html
Email sakigiy@juntendo.ac.jp

Sponsor
Institute Juntendo university hospital department of dermatology
Institute
Department

Funding Source
Organization Juntendo university hospital department of dermatology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor GIMRO
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 順天堂医院(東京都) Juntendo university hospital

Other administrative information
Date of disclosure of the study information
2013 Year 01 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 Open public recruiting
Date of protocol fixation
2012 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Presence or absence of adverse events

Management information
Registered date
2013 Year 01 Month 13 Day
Last modified on
2013 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011449

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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