UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003666 |
|---|---|
| Receipt number | R000004443 |
| Scientific Title | Open-labeled prospective randomized study between weekly and intensive(twice a week) treatment of GMA(granulocyte and monocyte absorption apheresis) for crohn disease |
| Date of disclosure of the study information | 2010/05/26 |
| Last modified on | 2015/11/26 20:29:45 |
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Basic information
Public title
Open-labeled prospective randomized study between weekly and intensive(twice a week) treatment of GMA(granulocyte and monocyte absorption apheresis) for crohn disease
Acronym
Open-labeled prospective randomized study between weekly and intensive(twice a week) treatment of GMA(granulocyte and monocyte absorption apheresis) for crohn disease
Scientific Title
Open-labeled prospective randomized study between weekly and intensive(twice a week) treatment of GMA(granulocyte and monocyte absorption apheresis) for crohn disease
Scientific Title:Acronym
Open-labeled prospective randomized study between weekly and intensive(twice a week) treatment of GMA(granulocyte and monocyte absorption apheresis) for crohn disease
Region
| Japan |
Condition
Condition
Crohn disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy between weekly and semiweekly treatment with GMA in a multicenter, prospective, randomized, controlled, non-blinded study for active crohn disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary measure of response was clinical remission at the end of the study (weekly GMA:11week,intensive GMA:6week).Clinical remission is defined as CDAI<150
Key secondary outcomes
Clinical remission at 6week
Clinical response at 6week
Clinical response is defined as 70points reduction in their CDAI
Reduction in CDAI
Reduction in CRP
Induction time to remission
Safety assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patiens in weekly GMA receive one treatment per week.The maximum number of treatments allowed is ten.
Interventions/Control_2
Patiens in intensive GMA receive two treatment per week. The maximum number of treatments allowed is ten.
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
| 12 | years-old | < |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Moderately and Severe active disease defined as a CDAI 200-449
Adequate peripheral venous access to allow for completion of the aphereis treatment
Able to provide informed consent
Insufficient or resistant to conventional therapies, and not applicable to conventional therapies
Key exclusion criteria
Granulocyte count is equal to or less than 2,000/mm3
Serious infectious disease
Serious heart disease
Serious kidney disease
Hypotonicity (less than maximum blood pressure 80mmHg)
Pregnancy
Serious exsiccation /Serious coagulation, Serious anemia (under haemoglobin 8g/dl)
Malignancy
Short-bowel syndrome
Permanent ostomy
External fistula and poor control anal fistula
Total colectomy
Intestinal stenosis to cause intestinal obstruction
Serious parenteral complication
Introduce or increase the dosage of Steroids (Intravenous infusion,oral,enema,suppository) within the last 1 weeks
Introduce or increase the dosage of
Use of Adalimumab with in last 2 weeks
Introduce or increase the dosage of Use of total Infliximab with in last 6 weeks
Operation (including strictureplasty) for bowel within 12 weeks
Treated in clinical trials and other treatment not covered by insurance
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshifumi Hibi |
Organization
Keio University Hospital
Division name
Division of Gastroenterology and Hepatology,Drpartment of Internal Medicine
Zip code
Address
35 Shinanomachi Shinjuku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University Hospital
Division name
Division of Gastroenterology and Hepatology,Drpartment of Internal Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Division of Gastroenterology and Hepatology,Drpartment of Internal Medicine,Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
JIMRO Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Keio Center for Clinical Research
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
札幌厚生病院（北海道）、弘前大学医学部附属病院（青森県）、岩手医科大学病院(岩手県)、国立病院機構仙台医療センター(宮城県)、仙台赤十字病院(宮城)、埼玉医科大学総合医療センター(埼玉県)、東邦大学医療センター佐倉病院（千葉県）、千葉大学医学部附属病院(千葉県)、東京慈恵会医科大学附属病院(東京都)、慶應大学病院（東京都）、東京医科歯科大学医学部附属病院、東京女子医科大学病院（東京都）、社会保険中央総合病院（東京都）、順天堂大学医学部附属順天堂医院(東京都)、江東高齢者医療センター(東京都)、大船中央病院（神奈川県）、横浜市立大学市民総合医療センター(神奈川県)、北里大学東病院(神奈川県)、浜松南病院(静岡県)、沼津市立病院(静岡県)、藤田保健衛生大学（愛知県）、名古屋市立大学(愛知県)、愛知医科大学(愛知県)、四日市社会保険病院（三重県）、滋賀医科大学病院（滋賀県）、富山県立中央病院(富山県)、金沢大学病院(金沢県)、京都大学医学部附属病院（京都府）、大阪市立大学病院（大阪府）、済生会中津病院(大阪府)、泉大津市立病院(大阪府)、生駒内科･消化器内科クリニック(大阪府)、兵庫医科大学病院（兵庫県）、和歌山県立医科大学(和歌山県)、島根大学医学部附属病院(島根県)、岡山大学病院（岡山県）、広島大学病院（広島県）、松山赤十字病院(愛媛県)、福岡大学筑紫病院（福岡県）、佐賀大学医学部附属病院(佐賀県)、久留米大学病院(福岡県)、長崎大学病院(長崎県)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 26 | Day |
Last modified on
| 2015 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004443
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| Registered date | File name |
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| Registered date | File name |
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