UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027096 |
|---|---|
| Receipt number | R000031039 |
| Scientific Title | Use experience of tolvaptan for end stage liver disease waiting for liver transplantation. |
| Date of disclosure of the study information | 2017/04/21 |
| Last modified on | 2017/04/21 21:22:12 |
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Basic information
Public title
Use experience of tolvaptan for end stage liver disease waiting for liver transplantation.
Acronym
Use experience of tolvaptan for end stage liver disease waiting for liver transplantation.
Scientific Title
Use experience of tolvaptan for end stage liver disease waiting for liver transplantation.
Scientific Title:Acronym
Use experience of tolvaptan for end stage liver disease waiting for liver transplantation.
Region
| Japan |
Condition
Condition
end stage liver disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There has been no reports which described the use experience of Tolvaptan for the end stage of liver disease waiting for liver transplantation. This study is to elucidate efficacy and safety of using tolvaptan for the end stage liver disease complicated by refractory ascites.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of body weight after initiation
Key secondary outcomes
urine volume,total-bilirubin,creatinine,sodium,Child-Pugh score,MELD score,Clavien-Dindo score,post operative day,readmission
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients in end stage liver disease who was complicated by refractory ascites and was adaptive for liver transplantation
Key exclusion criteria
1.poor oral intake
2.past history to administrate tolvaptan
3.rejection by patients
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Kaneko |
Organization
The University of Tokyo
Division name
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338155411
sho.kiritani@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sho Kiritani |
Organization
The University of Tokyo
Division name
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338155411
Homepage URL
sho.kiritani@gmail.com
Sponsor or person
Institute
The University of Tokyo
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 04 | Month | 21 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
finished the observation of 10 patients and now analyzing the data
Management information
Registered date
| 2017 | Year | 04 | Month | 21 | Day |
Last modified on
| 2017 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031039
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| Registered date | File name |
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