UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022265 |
|---|---|
| Receipt number | R000025651 |
| Scientific Title | Effect of steroids on leukocytapheresis. |
| Date of disclosure of the study information | 2016/05/10 |
| Last modified on | 2018/05/14 12:49:39 |
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Basic information
Public title
Effect of steroids on leukocytapheresis.
Acronym
Effect of steroids on leukocytapheresis.
Scientific Title
Effect of steroids on leukocytapheresis.
Scientific Title:Acronym
Effect of steroids on leukocytapheresis.
Region
| Japan |
Condition
Condition
ulcerative colitis, Crohn's disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of steroids on leukocytapheresis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of the expression of leukocyte adhesion molecules and immunoglobulin.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. moderate to severe UC patients.
2. Patients refractory to high dose 5-ASA agents.
Key exclusion criteria
1. Re-registered patients.
2. Patients whose granulocyte count below 2,000/mm3.
3. Patients with or suspected to have severe infection.
4. Patients with serious heart disease.
5. Patients with serious kidney disorder.
6. Patients with hypotension (mamimal blood pressure below 80mmHg).
7. Pregnant patients
8. Patients with serious dehydration, serious coagulation abnormality, or serious anemia (Hb below 8.0d/dL).
9. Patients with malignancy.
10. Patients who have severe extraintestinal complications.
11.Patients who are judged to be ineligible by an investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Namiko Hoshi |
Organization
Kobe University Hospital
Division name
Depertment of gastroenterology
Zip code
Address
7-5-2, kusunoki-cho, chuuou-ku, kobe,Japan
TEL
078-382-5111
nhoshi@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Namiko Hoshi |
Organization
Kobe University Hospital
Division name
Depertment of gastroenterology
Zip code
Address
7-5-2, kusunoki-cho, chuuou-ku, kobe,Japan
TEL
078-382-5111
Homepage URL
nhoshi@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 10 | 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
| 2015 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
2 patients are enrolled(May 10, 2016)
Management information
Registered date
| 2016 | Year | 05 | Month | 10 | Day |
Last modified on
| 2018 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025651
