UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009775
Receipt number 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 17:09:37

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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 or person

Institute

Juntendo university hospital department of dermatology

Institute

Department

Personal name



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

Value
https://center6.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