UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046629 |
|---|---|
| Receipt number | R000053193 |
| Scientific Title | A Prospective Multicenter Cohort Study on the Safety and Efficacy of Lusutrombopag during Hemostatic Procedures in Chronic Liver Disease |
| Date of disclosure of the study information | 2022/01/14 |
| Last modified on | 2024/06/22 14:34:54 |
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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
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
yoshida_hideo@med.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
July 2023BMC Gastroenterology 23(1) https://pubmed.ncbi.nlm.nih.gov/37488476/
Number of participants that the trial has enrolled
91
Results
PLT count was elevated from 44000 plus-minus 14000 to 86000 plus-minus 25000. Lusutrombopag administration prevented PLT transfusions in 84/91 patients (92%). No patient had bleeding complications after RFA. One had portal thrombosis after lusutrombopag administration.
Results date posted
| 2024 | Year | 06 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 07 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
Part of results are published
Management information
Registered date
| 2022 | Year | 01 | Month | 13 | Day |
Last modified on
| 2024 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053193
