UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of leukocytapheresis (LCAP) in combination with tacrolimus for active ulcerative colitis.
Title of the study (Brief title)	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	Takayuki Matsumoto
Organization	Iwate Medical University
Division name	Division of Gastroenterology, Department of Internal Medicine
Address	19-1 Uchimaru, Morioka, Iwate
TEL	019-651-5111
Email	syanai@iwate-med.ac.jp

Public contact
Name of contact person	Shunichi Yanai
Organization	Iwate Medical University
Division name	Division of Gastroenterology, Department of Internal Medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 04 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	We could not accumulate appropriate patients for this study.
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