UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054697 |
|---|---|
| Receipt number | R000062496 |
| Scientific Title | Prospective Study on the Efficacy of Avatrombopag Maleate Administration for Biliary Procedures in Chronic Liver Disease Patients with Thrombocytopenia |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/06/18 19:18:31 |
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Basic information
Public title
Prospective Study on the Efficacy of Avatrombopag Maleate Administration for Biliary Procedures in Chronic Liver Disease Patients with Thrombocytopenia
Acronym
APBT Study
Scientific Title
Prospective Study on the Efficacy of Avatrombopag Maleate Administration for Biliary Procedures in Chronic Liver Disease Patients with Thrombocytopenia
Scientific Title:Acronym
APBT Study
Region
| Japan |
Condition
Condition
obstructive jaundice
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Avatrombopag Maleate administration in patients with chronic liver disease and thrombocytopenia undergoing high-risk bleeding biliary endoscopic procedures (EST, EUS-BD).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The presence or absence of post-procedural bleeding after endoscopic treatment:
For cases undergoing EST (Endoscopic Sphincterotomy) or EUS-BD (Endoscopic Ultrasound-Guided Biliary Drainage), the presence of bleeding will be confirmed on the day after the procedure, 3 days after, and 7 days after. Post-procedural bleeding is defined as a decrease in Hb by 2 g/dL or more, or the presence of overt symptoms such as melena or hematemesis.
Key secondary outcomes
Severity of Post-Procedure Bleeding and Other Complications After Endoscopic Treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
endoscopic biliary procedures:EST,EUS-BD
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Presence of chronic liver disease
Platelet count less than 50000 per microliter
Age at registration is 18 years or older and less than 90 years
Written informed consent for participation in the study has been obtained from the study subject themselves
Key exclusion criteria
Platelet count greater than or equal to 50000 per microliter
Cases with current pregnancy
Cases with severe complications in other organs : ASA classification of 3 or higher (including dialysis patients)
ECOG performance status 4
Patients in a moribund state with a life expectancy of less than 3 months
Other cases deemed unsuitable by the principal investigator or co-investigator as study subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical and Pharmaceutical University
Division name
Endoscopy Center
Zip code
569-8686
Address
2-7,Daigakumachi,Takatsuki City,Osaka
TEL
0726831221
takeshi.ogura@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Okuda |
Organization
Osaka Medical and Pharmaceutical University
Division name
2nd department of internal medicine
Zip code
569-8686
Address
2-7,Daigakumachi,Takatsuki City,Osaka
TEL
0726831221
Homepage URL
atsushi.okuda@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Atsushi Okuda
Funding Source
Organization
not present
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
Osaka Medical and Pharmaceutical University
Address
2-7,Daigakumachi,Takatsuki City,Osaka
Tel
0726831221
atsushi.okuda@ompu.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2024 | Year | 06 | Month | 18 | Day |
Last modified on
| 2024 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062496
