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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000026767
Receipt No. 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

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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
Email 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
Email syanai@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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