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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021896
Receipt No. R000025252
Scientific Title Tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis
Date of disclosure of the study information 2016/04/13
Last modified on 2016/04/13

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Basic information
Public title Tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis
Acronym Tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis
Scientific Title Tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis
Scientific Title:Acronym Tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis
Region
Japan

Condition
Condition Ulcernative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Early efficacy and safety of tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Efficacy rate after 12 weeks(partial DAI score and Lichtiger score)
Key secondary outcomes 1, Remission rate after 12 weeks
2, DAI score and Lichtiger score after 12 weeks
3, Endoscopic remission rate after 12 weeks(mucosal healing)
4, The condition of reactivation(Presence or absence of reactivation and time to reactivation)
5, Safety(Presence or absence of adverse eventes and abnormality of laboratory values)
6, Efficacy of steroid taper
7, Influences efficacy of factor for patient background and therapy
8, Relationship with gene polymorphism of CYP3A5 and efficacy of tacrolimus and trough levels

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with moderate to severe ulcerative colitis
Key exclusion criteria Patients who contraindicate for tacrolimus. Patients who contraindicate for tacrolimus.
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Matui, MD, PhD.
Organization Fukuoka University Chilushi Hospital
Division name Department of Gastroenterology
Zip code
Address Zokumyouin 1-1-1, Chikushino, Fukuoka
TEL 092-921-1011
Email matsui@fukuoka-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Fumihito Hirai
Organization Fukuoka University Chilushi Hospital
Division name Department of Gastroenterology
Zip code
Address Zokumyouin 1-1-1, Chikushino, Fukuoka
TEL 092-921-1011
Homepage URL
Email fuhirai@cis.fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Chilushi Hospital
Department of Gastroenterology
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
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
2016 Year 04 Month 13 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 Enrolling by invitation
Date of protocol fixation
2014 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Early efficacy and safety of tacrolimus therapy in Japanese patients with refractory moderate ulcerative colitis.

Management information
Registered date
2016 Year 04 Month 13 Day
Last modified on
2016 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025252

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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