UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026767 |
|---|---|
| Receipt number | R000030650 |
| Scientific Title | Efficacy and safety of leukocytapheresis (LCAP) in combination with tacrolimus for active ulcerative colitis. |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/04/25 17:20:15 |
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Basic information
Public title
Efficacy and safety of leukocytapheresis (LCAP) in combination with tacrolimus for active ulcerative colitis.
Acronym
Efficacy and safety of LCAP with tacrolimus for ulcerative colitis.
Scientific Title
Efficacy and safety of leukocytapheresis (LCAP) in combination with tacrolimus for active ulcerative colitis.
Scientific Title:Acronym
Efficacy and safety of LCAP with tacrolimus for ulcerative colitis.
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of leukocytapheresis with tacrolimus in patients with active UC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical response rate
(Lichtiger score, DAI score)
Key secondary outcomes
(1)comparison of the rate of DAI score improvement and mucosal healing with the past study.
(2)UCEIS
(3)change of the laboratory data
(4)change of the dosage of corticosteroid.
(5)the number and variety of adverse events
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
| 16 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
UC patients who satisfy the following all conditions
(1) treated by tacrolimus
(2) treated by the maximum dose 5-ASA
(3) >=16 years old,=<85 years old when agree the participation of this research
(4) Disease extent: total or left-sided
Key exclusion criteria
Patients who satisfy the folloing any conditions
(1) disease extent: rectal
(2) leukocyte count < 3,000mm3 or platelet count < 100,000mm3
(3) diagnosed with fulminant UC
(4) with deep or wide range ulceration, serious bleeding, performation, or toxic megacolon.
(5) With severe cardiovascular, liver, kidney, respiratory, metabolic, or nervous diseases
(6) Taking Anti-Angiotensin Converting Enzyme Antibody
(7) Newly administerd or increased dose of thioprines within 8 weeks prior to LCAP
(8) Administerd biological agents or Cyclosporin within 8 weeks prior to LCAP
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Matsumoto |
Organization
Iwate Medical University
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
19-1 Uchimaru, Morioka, Iwate
TEL
019-651-5111
syanai@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunichi Yanai |
Organization
Iwate Medical University
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
19-1 Uchimaru, Morioka, Iwate
TEL
019-651-5111
Homepage URL
syanai@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
ASAHI KASEI MEDICAL CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 04 | Month | 01 | 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
We could not accumulate appropriate patients for this study.
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
Terminated
Date of protocol fixation
| 2016 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
ulcerative colitis cases who treated by tacrolimus that adapted to criteria for selection
case registration period: From July 2016 to July 2018.
measurement items: complete blood count, clinical chemistry tests, Clinical response rate, UCEIS
Management information
Registered date
| 2017 | Year | 03 | Month | 29 | Day |
Last modified on
| 2018 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030650
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
