UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013095 |
|---|---|
| Receipt number | R000015046 |
| Scientific Title | Multicenter study of the efficacy of tolvaptan for patients with refractory ascites. |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2020/08/12 10:00:39 |
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Basic information
Public title
Multicenter study of the efficacy of tolvaptan for patients with refractory ascites.
Acronym
Eeffect of tolvaptan on refractory ascites.
Scientific Title
Multicenter study of the efficacy of tolvaptan for patients with refractory ascites.
Scientific Title:Acronym
Eeffect of tolvaptan on refractory ascites.
Region
| Japan |
Condition
Condition
Liver cirrhosis with refractory ascites.
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the efficacy of tolvaptan, competitive vasopressin receptor 2 antagonist, for cirrhotic patients with reflactory ascites.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Decrease of body weight.
Key secondary outcomes
Improvement of ascites.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Use tolvaptan 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
100
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
Shijyo-cho 840, Kashihara, Nara, Japan
TEL
0744-22-3051(3415)
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
Shijyo-cho 840, Kashihara, Nara, Japan
TEL
0744-22-3051(3415)
Homepage URL
kawara@naramed-u.ac.jp
Sponsor or person
Institute
Tht third department of internal medicine, Nara Medical University
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
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
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
奈良県立医科大学附属病院（奈良県）
奈良県立奈良病院（奈良県）
独立行政法人国立病院機構 奈良医療センター（奈良県）
県立五條病院（奈良県）
国保中央病院（奈良県）
県立三室病院（奈良県）
高の原中央病院（奈良県）
西奈良中央病院（奈良県）
大倭病院（奈良県）
高宮病院（奈良県）
服部記念病院（奈良県）
平成記念病院（奈良県）
済生会御所病院（奈良県）
ベルランド総合病院（大阪府）
医真会八尾総合病院（大阪府）
堺若葉会病院（大阪府）
その他臨床研究賛同施設
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
413
Results
GWAS were performed. Gene A was identified.
Results date posted
| 2020 | Year | 02 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
413 patients with liver cirrhosis were enrolled.
Participant flow
413 patients with liver cirrhosis were enrolled.
Adverse events
No
Outcome measures
GWAS were preformed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 02 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Factors to consider the relevance and results
Management information
Registered date
| 2014 | Year | 02 | Month | 06 | Day |
Last modified on
| 2020 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015046
| Research Plan | |
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| 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 |
