UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023734
Receipt number R000026881
Scientific Title Leukocytapheresis with double column, Cellsorba E for refractory ulcerative colitis
Date of disclosure of the study information 2016/08/24
Last modified on 2018/11/01 12:18:58

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Basic information

Public title

Leukocytapheresis with double column, Cellsorba E for refractory ulcerative colitis

Acronym

LEADER study

Scientific Title

Leukocytapheresis with double column, Cellsorba E for refractory ulcerative colitis

Scientific Title:Acronym

LEADER study

Region

Japan


Condition

Condition

ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Optimization of LCAP for ulcerative colitis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

endoscopic findings at two-weeks after the first LCAP

Key secondary outcomes

1. clinical efficacy at 2, 4 and 24 weeks after the first LCAP
2. fecal occult blood at 2, 4 and 24 weeks after the first LCAP
3. histological findings at 2 and 24 weeks after the first LCAP
4. endoscopic findings at 24weeks later


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment

Interventions/Control_1

four-times leukocytoapheresis with double column

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1.refractory ulcerative colitis
2.written informed consent

Key exclusion criteria

1.proctitis type
2.under the age of 20
3.patients taking ACE inhibiter
4.patients with hypersensitivity to nafamostat mesylate

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirotake Sakuraba

Organization

Hirosaki University Graduate School of Medicine

Division name

Dept. Gastroenterology and Hematorogy

Zip code


Address

5 Zaifu-cho, Hirosaki, Aomori, 036-8562, Japan

TEL

0172-33-5111

Email

hirotake@infoaomori.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hidezumi Kikuchi

Organization

Hirosaki University Graduate School of Medicine

Division name

Dept. Gastroenterology and Hematorogy

Zip code


Address

5 Zaifu-cho, Hirosaki, Aomori, 036-8562, Japan

TEL

0172-33-5111

Homepage URL


Email

hidezumi@hirosaki-u.ac.jp


Sponsor or person

Institute

Hirosaki Univeresity Hospital
Department of Gastroenterology and Hematology

Institute

Department

Personal name



Funding Source

Organization

Asahi KASEI 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

2016 Year 08 Month 24 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

2016 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 08 Month 23 Day

Last modified on

2018 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026881


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name