UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026426 |
|---|---|
| Receipt number | 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 | 2025/03/27 15:03:49 |
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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 | Hideto |
| Middle name | |
| Last name | Kawaratani |
Organization
Nara Medical University
Division name
The third department of internal medicine
Zip code
634-8522
Address
840 Shijo-cho Kashihara, Nara
TEL
0744-22-3051
kawara@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideto |
| Middle name | |
| Last name | Kawaratani |
Organization
Nara Medical University
Division name
The third department of internal medicine
Zip code
634-8522
Address
840 Shijo-cho Kashihara, Nara
TEL
0744-22-3051
Homepage URL
kawara@naramed-u.ac.jp
Sponsor or person
Institute
The third department of internal medicine, Nara Medical University
Institute
Department
Personal name
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
IRB of Nara Medical University
Address
840 Shijo-cho Kashihara, Nara
Tel
0744-22-3051
ino_rinri@naramed-u.ac.jp
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
30
Results
Not available
Results date posted
| 2023 | Year | 07 | Month | 12 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Due to small number
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 | 01 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 12 | Day |
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
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030283
