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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000046629 |
Receipt No. | 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 | 2022/07/21 |
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 |
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Condition | ||
Condition | Hepatocellular Carcinoma | |
Classification by specialty |
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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
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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 |
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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 |
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Age-upper limit |
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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. |
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Key exclusion criteria | None | |||
Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | on goingf |
Management information | |||||||
Registered date |
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Last modified on |
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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 |