UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter study of Genome-Wide Association Study (GWAS) concerning of the efficacy of tolvaptan.
Acronym	Effect of tolvaptan on refractory ascites.
Scientific Title	Multicenter study of Genome-Wide Association Study (GWAS) concerning of the efficacy of tolvaptan.
Scientific Title:Acronym	Effect of tolvaptan on refractory ascites.
Region	Japan

Condition
Condition	Liver cirrhosis with refractory ascites.
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To elucidate the gene concerning for the efficacy of tolvaptan, competitive vasopressin receptor 2 antagonist, for cirrhotic patients with reflactory ascites by using GWAS.
Basic objectives2	Others
Basic objectives -Others	Identification of genes affecting therapeutic effect of tolvaptan.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Decrease of body weight.
Key secondary outcomes	Improvement of ascites. Increase of urine volume. Improvement of patient's symptom.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of tolvaptan (7.5mg/day) for a refractory ascites patients.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients over 20 years old 2)Patients obtained written informed consent 3) Life expectancy of at least 4 weeks 4) Adequate organ function a) Hb>= 8.0g/dL b) neutrophil: >= 1,500/mm3 c) Platelet: >= 30,000/mm3 d) Total bilirubin:< 4.0 mg/dL e) ALT and AST: <= within 6 folds of normal limit f) Serum creatine: <= 2.0 mg/dL g) Serum natrium: >= 120mEq/L
Key exclusion criteria	1) Adequate cardiac organ function a) Patients with conjestive heart failure above NYHA class3 b) Patients with severe hypertension 2) Patients with severe and active infectious disease (exclude HBV,HCV hepatitis) 3) Patients with HIV 4) Patients taking dialysis 5) Patients with portal tumor thrombosis (Vp3 or Vp4) 6) Patients with hepatic encephalopathy 7) Patients with crutial digestive bleedings within 4 weeks 8) Patients with the following treatment a) Systemic chemotherapy b) Being treated with invasive surgical therapy within 4 weeks 9) Patients with oral intake difficulty 10)Patients with severe digestive diseases 11)Patients taking a tablet which would affect this clinical study 12)Pregnant woman, lactating woman, or a woman suspected of pregnancy 13)Patients with severe allergic reaction to Tolvaptan 14)Patients with drug abuse or psycological disorders 15) Patients concluded to be inappropriate to participate in this study by their physitians
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hideto Kawaratani
Organization	Nara Medical University
Division name	The third department of internal medicine
Zip code
Address	Shijyo-cho 840, Kashihara, Nara, Japan
TEL	0744-22-3051(3415)
Email	kawara@naramed-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hideto Kawaratani
Organization	Nara Medical University
Division name	The third department of internal medicine
Zip code
Address	Shijyo-cho 840, Kashihara, Nara, Japan
TEL	0744-22-3051(3415)
Homepage URL
Email	kawara@naramed-u.ac.jp

Sponsor
Institute	The third department of internal medicine, Nara Medical University
Institute
Department

Funding Source
Organization	Nagoya city University
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Japan

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	研究協力施設

Other administrative information
Date of disclosure of the study information	2017 Year 02 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	Completed
Date of protocol fixation	2017 Year 02 Month 01 Day
Date of IRB	2016 Year 12 Month 13 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 01 Month 30 Day
Last modified on	2020 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029337