UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020094 |
|---|---|
| Receipt number | R000023217 |
| Scientific Title | Tolvaptan as A treatment for Refractory Cirrhotic Ascites in Japanese population (TARCAJa study) |
| Date of disclosure of the study information | 2015/12/07 |
| Last modified on | 2016/12/07 12:50:38 |
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Basic information
Public title
Tolvaptan as A treatment for Refractory Cirrhotic Ascites in Japanese population (TARCAJa study)
Acronym
Tolvaptan as A treatment for Refractory Cirrhotic Ascites in Japanese population(TARCAja study)
Scientific Title
Tolvaptan as A treatment for Refractory Cirrhotic Ascites in Japanese population (TARCAJa study)
Scientific Title:Acronym
Tolvaptan as A treatment for Refractory Cirrhotic Ascites in Japanese population(TARCAja study)
Region
| Japan |
Condition
Condition
Cirrhotic patients with ascites unresponsive to standard diuretic therapy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficay of Tolvaptan in patients with ascites unresponsive to standard diuretic therapy, and to elucidate the factors which contributed to the alterlations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Alterlation of ascites and hyponatremia
Key secondary outcomes
Overall survival, safty, and changes in parameter
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
administration of tolvaptan(3.75-7.5mg/day)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Obtained informed consent form from patients. Unresponsiveness to standard diuretic therapies.
Key exclusion criteria
Alergy to tolvaptan.
Renal failure patients.
Diffcult to drink water.
Hypernatremia patients.
Heptatic encephalopathy patients.
Pregnancy.
Other patients who doctors judged as not suitable for this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takamasa Ohki |
Organization
Mitsui Memorail Hospital
Division name
Gastroenterology
Zip code
Address
Kanda-Izumicho 1 Chiyoda ward Tokyo
TEL
03-3862-9111
anb72547@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamasa Ohki |
Organization
Mitsui Memorail Hospital
Division name
Gastroenterology
Zip code
Address
Kanda-Izumicho 1 Chiyoda ward Tokyo
TEL
03-3862-9111
Homepage URL
anb72547@nifty.com
Sponsor or person
Institute
Mitsui Memorail Hospital Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
All treatments were within insurance of Japan.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoundo hospital
Kanto chuo hospital
Japanese red cross hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
三井記念病院(東京)
杏雲堂病院(東京)
関東中央病院(東京)
日赤医療センター(東京)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | 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
| 2015 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 07 | Day |
Last modified on
| 2016 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023217
