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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025776
Receipt No. R000029353
Scientific Title Predictors for therapeutic effect of Lusutrombopag in chronic liver disease
Date of disclosure of the study information 2017/01/20
Last modified on 2018/02/18

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Basic information
Public title Predictors for therapeutic effect of Lusutrombopag in chronic liver disease
Acronym Predictors of Lusutrombopag
Scientific Title Predictors for therapeutic effect of Lusutrombopag in chronic liver disease
Scientific Title:Acronym Predictors of Lusutrombopag
Region
Japan

Condition
Condition Chronic liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the predictors for therapeutic effect of Lusutrombopag in chronic liver ddisease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate (more than 50,000 /mm^3) at after adminstraion of lusutrombopag.
Key secondary outcomes 1.Increase rate of Platelet count.
2.Correlation with increase rate and thrombopoietin.
3.Correlation with increase rate and megakaryocyte.
4.Correlation with increase rate and portal hypertention.
5.Adverse event occurrence rate.

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
Interventions/Control_1 Multicenter, single-arm, open-label trial
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Platelet count<50*10^9/L in liver cirrhosis patient.
2.age >20
3.patients received a fully described on the basis of informed consent document
Key exclusion criteria 1.Patients with a hematologic malignancy.
2.Active malignancy at time of study entry except HCC.
3.Patients who underwent liver transplantation
4.Patients with a severe liver dysfunction (Child-pugh C)
5.Patients with a medical history of thrombosis.
6.Patients with a medical history of thrombotic disease adult patients.
7.Women who are pregnant or breastfeeding
8.Severe GI bleeding.
9.Not appropriate for this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Uojima Haruki
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
TEL 042-778-8390
Email kiruha@kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Uojima Haruki
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
TEL 042-778-8390
Homepage URL
Email kiruha@kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Kitasato University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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 01 Month 20 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 Open public recruiting
Date of protocol fixation
2017 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 15 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
2017 Year 01 Month 20 Day
Last modified on
2018 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029353

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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