UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017318 |
|---|---|
| Receipt number | R000020038 |
| Scientific Title | An exploratory study of susceptible factors to tolvaptan treatment in hepatic edema |
| Date of disclosure of the study information | 2015/04/28 |
| Last modified on | 2022/08/25 13:47:40 |
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Basic information
Public title
An exploratory study of susceptible factors to tolvaptan treatment in hepatic edema
Acronym
An exploratory study of susceptible factors to tolvaptan treatment in hepatic edema
Scientific Title
An exploratory study of susceptible factors to tolvaptan treatment in hepatic edema
Scientific Title:Acronym
An exploratory study of susceptible factors to tolvaptan treatment in hepatic edema
Region
| Japan |
Condition
Condition
Liver cirrhosis with refractory hepatic edema
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Analyzes the relationship between various parameters and effectiveness, including SNP, to be exhaustively explore the factors involved in tolvaptan susceptibility
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decrease of body weight after 7 days of tolvaptan treatment
Key secondary outcomes
SNP analysis
Blood biochemical findings
Body composition change by In body
Symptom change by ASI-7
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tolvaptan 3.75mg or 7.5mg
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Liver cirrhosis with refractory hepatic edema despite undergoing therapy with furosemide 20mg/day or more and spironolactone 25mg/day or more
2)Patients obtained written informed consent
Key exclusion criteria
1)Alcoholic hepatitis and cirrhosis patients in continued drinking
2)Patients with overt hepatic encephalopathy
3)Patients with requiring treatment for esophageal, gastric or rectal varices
4)Hepatocellular carcinoma with life expectancy less than 3 months
5)The anuria patints (including dialysis patients)
6)Patients with urinary excretion failure
7)Patients with oral intake difficulty
8)Patients receiving albumin within 7 days before the test
9)Patients with unsuitable condition for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Arase |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
shimokasuya 143, Isehara, Kanagawa, Japan
TEL
0463-93-1121
arase@tokai-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Arase |
Organization
Tokai University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
shimokasuya 143, Isehara, Kanagawa, Japan
TEL
0463-93-1121
Homepage URL
arase@tokai-u.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Tokai University 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
東海大学医学部付属病院（神奈川）
東海大学医学部付属大磯病院（神奈川）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 28 | 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
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Susceptible factors to tolvaptan treatment in hepatic edema
Management information
Registered date
| 2015 | Year | 04 | Month | 28 | Day |
Last modified on
| 2022 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020038
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
