UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031505 |
|---|---|
| Receipt number | 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 | 2020/09/30 19:22:15 |
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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 | Naoki |
| Middle name | |
| Last name | Hosoe |
Organization
Keio University school of medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35 shinanomachi shinjuku-ku tokyo Japan
TEL
03-5363-3238
nhosoe@z5.keio.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Takabayashi |
Organization
Keio University school of medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35 shinanomachi shinjuku-ku tokyo Japan
TEL
03-5363-3238
Homepage URL
kaoru0902@yahoo.co.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, Keio University,
Institute
Department
Personal name
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
Keio University school of medicine
Address
35 shinanomachi shinjuku-ku tokyo Japan
Tel
03-5363-3879
med-rinri-jimu@adst.keio.ac.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
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
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
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
| 2020 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035949
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| Registered date | File name |
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