UMIN-CTR Clinical Trial

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
Email	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
Email	arase@tokai-u.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Tokai University School of Medicine
Institute
Department

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
Email

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020038