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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032777
Receipt No. R000037394
Official scientific title of the study Comparison between Lusutrombopag and effectiveness of the platelet blood transfusion
Date of disclosure of the study information 2018/06/13
Last modified on 2018/05/30

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Basic information
Official scientific title of the study Comparison between Lusutrombopag and effectiveness of the platelet blood transfusion
Title of the study (Brief title) The usefulness of Lusutrombopag
Region
Japan

Condition
Condition Thrombopenia
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Inspection of the platelet growth rate of Lusutrombopag
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Platelet growth rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Lusutrombopag
Interventions/Control_2 Platelet transfusion
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
90 years-old >
Gender Male and Female
Key inclusion criteria Thrombopenia having the chronic liver disease that scheduled elective bloody treatment
Child-pugh A or B
Key exclusion criteria Child-pugh C
Target sample size 80

Research contact person
Name of lead principal investigator Hirohito Takeuchi
Organization Gastroenterology and Hepatology
Division name Tokyo Medical University
Address 6-7-1 NISHI-SHINJUKU, TOKYO, JAPAN
TEL 0333426111
Email htake@tokyo-med.ac.jp

Public contact
Name of contact person Hirohito Takeuchi
Organization Gastroenterology and Hepatology
Division name Tokyo Medical University
Address 6-7-1 NISHI-SHINJUKU, TOKYO, JAPAN
TEL 0333426111
Homepage URL
Email htake@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization Tokyo Medical University
Organization
Division
Category of Funding Organization Other
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
2018 Year 06 Month 13 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 05 Month 30 Day
Anticipated trial start date
2018 Year 06 Month 13 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
Other related information

Management information
Registered date
2018 Year 05 Month 30 Day
Last modified on
2018 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037394

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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