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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026426
Receipt No. R000030283
Scientific Title A Study on predictors of treatment response concerning of the efficacy of tolvaptan on refractory ascites.
Date of disclosure of the study information 2017/03/07
Last modified on 2019/03/08

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Basic information
Public title A Study on predictors of treatment response concerning of the efficacy of tolvaptan on refractory ascites.
Acronym Effect of tolvaptan on refractory ascites.
Scientific Title A Study on predictors of treatment response concerning of the efficacy of tolvaptan on refractory ascites.
Scientific Title:Acronym Effect of tolvaptan on refractory ascites.
Region
Japan

Condition
Condition Liver cirrhosis with refractory ascites.
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the parameters concerning for the efficacy of tolvaptan, competitive vasopressin receptor 2 antagonist, for cirrhotic patients with refractory ascites.
Basic objectives2 Others
Basic objectives -Others Identification of the parameters affecting therapeutic effect of tolvaptan.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Over 1.5kg decrease of body weight.
Key secondary outcomes Increase of urine volume.
Improvement of physical symptom.
Improvement of patient's symptom by using questionnaire (ASI-7 and CLD-Q).

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 psychological disorders
15) Patients concluded to be inappropriate to participate in this study by their physicians
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 840 Shijo-cho Kashihara, Nara
TEL 0744-22-3051
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 840 Shijo-cho Kashihara, Nara
TEL 0744-22-3051
Homepage URL
Email kawara@naramed-u.ac.jp

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

Funding Source
Organization The third department of internal medicine, Nara Medical University
Organization
Division
Category of Funding Organization Self funding
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 03 Month 07 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 Open public recruiting
Date of protocol fixation
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
2023 Year 03 Month 31 Day
Date analysis concluded
2023 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 06 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030283

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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