UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031505
Receipt No. R000035949
Scientific Title Randomized-controlled trial to evaluate the efficacy of Lusutrombopag on EVL-AS therapy in thrombocytopenic patients
Date of disclosure of the study information 2018/02/27
Last modified on 2018/08/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized-controlled trial to evaluate the efficacy of Lusutrombopag on EVL-AS therapy in thrombocytopenic patients
Acronym Randomized-controlled trial to evaluate the efficacy of Lusutrombopag on EVL-AS therapy in thrombocytopenic patients
Scientific Title Randomized-controlled trial to evaluate the efficacy of Lusutrombopag on EVL-AS therapy in thrombocytopenic patients
Scientific Title:Acronym Randomized-controlled trial to evaluate the efficacy of Lusutrombopag on EVL-AS therapy in thrombocytopenic patients
Region
Japan

Condition
Condition Liver Cirrhosis,Esophageal varices
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Lusutrombopag on EVL-AS therapy in thrombocytopenic patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes total procedure time of EIS
Key secondary outcomes number of balloon compression times, bleeding time, delayed post EIS bleeding, adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lusutrombopag 3mg/day, oral intake for 7 days
Interventions/Control_2 no medication
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
85 years-old >
Gender Male and Female
Key inclusion criteria eligible patients had liver cirrhosis (Child-Pugh score A or B), and a platelet count of more than 40000 to less than 80000 per cubic millimeter.
Key exclusion criteria Patients were excluded if they had a history of hypersensitivity of lusutrombopag, or if
they were pregnant, or they had a history of arterial or venous thrombosis with on-going risk factors for thrombosis, or had a severe liver damages (Child-Pugh score C), or had a severe renal dysfunction, or took anticoagulant or antiplatelet drug.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Hose
Organization Keio University school of medicine
Division name Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address 35 shinanomachi shinjuku-ku tokyo Japan
TEL 03-5363-3238
Email nhosoe@z5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaoru Takabayashi
Organization Keio University school of medicine
Division name Center for Diagnostic and Therapeutic Endoscopy
Zip code
Address 35 shinanomachi shinjuku-ku tokyo Japan
TEL 03-5363-3238
Homepage URL
Email kaoru0902@yahoo.co.jp

Sponsor
Institute Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Keio University,
Institute
Department

Funding Source
Organization Center for Diagnostic and Therapeutic Endoscopy, division of Keio University school of medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor National Hospital Organization Tokyo Medical Center
SANOKOUSEI GENERAL HOSPITAL
Kitasato Institute Hospital
Tokyo Dental College Ichikawa General Hospital
Tokyo Saiseikai Central Hospital
Yokohama Municipal Citizen's Hospital
Eiju Hospital
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 慶應義塾大学病院(東京都)
独立行政法人国立病院機構東京医療センター(東京都)
佐野厚生総合病院(栃木県) 
北里大学北里研究所病院(東京都) 
東京歯科大学市川総合病院(千葉県) 
東京都済生会中央病院(東京都) 
横浜市立市民病院(神奈川県) 
永寿総合病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 27 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
2018 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 27 Day
Last modified on
2018 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035949

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.