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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
