UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005293 |
|---|---|
| Receipt number | R000006296 |
| Scientific Title | Efficacy study by intensive Leukocytapheresis |
| Date of disclosure of the study information | 2011/03/23 |
| Last modified on | 2021/10/02 08:26:33 |
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Basic information
Public title
Efficacy study by intensive
Leukocytapheresis
Acronym
Multicenter cohort study of
Leukocytapheresis (LCAP) for Ulcerative
Colitis
(Kanagawa LCAP Study)
Scientific Title
Efficacy study by intensive
Leukocytapheresis
Scientific Title:Acronym
Multicenter cohort study of
Leukocytapheresis (LCAP) for Ulcerative
Colitis
(Kanagawa LCAP Study)
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Multicenter Cohort study of
Leukoctapheresis (LCAP) for Ulcerative
Colitis under the applied conditions of 5-ASA and Steroids.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical remission by partial Mayo score and average terms until clinical remission.
Key secondary outcomes
1.Clinical improvement rate by Lichtiger's CAI
2.Changing a Steroids dosage before and
after LCAP
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
| Device,equipment |
Interventions/Control_1
Interval of LCAP : 2 times/week for 2
weeks and 1 time/week for after 2 weeks
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
The patients with refractory moderate to
severe active ulcerative colitis who needs
LCAP
Key exclusion criteria
The treatment with immunomodulator
(azathioprine, 6-MP, tacrolimus and
cyclosporine), anti-TNF alpha agents and
angiotensin-converting enzyme inhibitor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YUTAKA ENDO, M.D. |
Organization
Showa University Fujigaoka Hospital
Division name
Division of Gastroenterology
Zip code
Address
1-30 Fujigaoka Aoba-ku, Kanagawa 227-8501, Japan
TEL
045-971-1151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YUTAKA ENDO, M.D. |
Organization
Showa University Fujigaoka Hospital
Division name
Division of Gastroenterology
Zip code
Address
TEL
Homepage URL
Y_endo2004@yahoo.co.jp
Sponsor or person
Institute
Showa University Fujigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
昭和大学藤ヶ丘病院(神奈川県)
昭和大学横浜市北部病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
大船中央病院(神奈川県)
関内鈴木クリニック(神奈川県)
松島クリニック(神奈川県)
聖マリアンナ医科大学病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 23 | 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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2010 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 09 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 23 | Day |
Last modified on
| 2021 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006296
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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