UMIN-CTR Clinical Trial

Basic information
Public title	A Prospective Multicenter Cohort Study on the Safety and Efficacy of Lusutrombopag during Hemostatic Procedures in Chronic Liver Disease
Acronym	Safety and Efficacy Study of Lusutrombopag
Scientific Title	A Prospective Multicenter Cohort Study on the Safety and Efficacy of Lusutrombopag during Hemostatic Procedures in Chronic Liver Disease
Scientific Title:Acronym	Safety and Efficacy Study of Lusutrombopag
Region	Japan

Condition
Condition	Hepatocellular Carcinoma
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To prospectively enroll patients with chronic liver disease who are scheduled for a wait-and-see hematologic procedure and who will receive lusutrombopag for low platelets, and to evaluate the therapeutic efficacy and safety of treatment for bleeding upon treatment.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Transfusion avoidance rate during procedures performed approximately 2 weeks after administration
Key secondary outcomes

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	Prevention
Type of intervention	Medicine
Interventions/Control_1	Lusutrombopag 3 mg was administered once a day for 7 days
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	Patients with low PLT levels (less than 50,000 PLT mcL-1) scheduled for RFA. Patients whose PLT count tended to decline, cases where the PLT count just before administration was more than 50,000, cases that had previously recorded less than 50,000, and those that fluctuated around 50,000, or were greater than, but around, 50,000.
Key exclusion criteria	None
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Hideo Middle name Last name Yoshida
Organization	Japanese Red Cross Medical Center
Division name	Department of Gastroenterology and Hepatology
Zip code	150-8935
Address	4-1-22 Hiro-o Shibuya-ku Tokyo
TEL	03-3400-1311
Email	yoshida_hideo@med.jrc.or.jp

Public contact
Name of contact person	1st name Hideo Middle name Last name Yoshida
Organization	Japanese Red Cross Medical Center
Division name	Department of Gastroenterology and Hepatology
Zip code	150-8935
Address	4-1-22 Hiro-o Shibuya-ku Tokyo
TEL	0334001311
Homepage URL
Email	yoshida_hideo@med.jrc.or.jp

Sponsor
Institute	Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization	Japanese Red Cross Medical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japanese Red Cross Medical Center
Address	4-1-22 Hiro-o Shibuya-ku Tokyo
Tel	0334001311
Email	yoshida_hideo@med.jrc.or.jp

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	2022 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2018 Year 02 Month 07 Day
Date of IRB	2018 Year 03 Month 07 Day
Anticipated trial start date	2018 Year 03 Month 07 Day
Last follow-up date	2028 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	2022 Year 01 Month 13 Day
Last modified on	2022 Year 01 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053193

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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