UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036589 |
|---|---|
| Receipt number | R000041681 |
| Scientific Title | Retrospective cohort analysis of the factor related to the effect of tolvaptan on the medium-and-long term prognosis in patients with hepatic edema |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2020/11/15 18:04:11 |
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Basic information
Public title
Retrospective cohort analysis of the factor related to the effect of tolvaptan on the medium-and-long term prognosis in patients with hepatic edema
Acronym
clinical trial of tolvaptan for hepatic edema
Scientific Title
Retrospective cohort analysis of the factor related to the effect of tolvaptan on the medium-and-long term prognosis in patients with hepatic edema
Scientific Title:Acronym
clinical trial of tolvaptan for hepatic edema
Region
| Japan |
Condition
Condition
hepatic edema
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate influence that tolvaptan for hepatic edema will give the prognosis of the cirrhotic patient, and intend that I clarify optimum time of the introduction of tolvaptan by clarifying the patient baseline factor which influenced the prognosis of the cirrhotic patient under tolvaptan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the survival days of the cirrhotic patientunder tolvaptan
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Age 20 years old or older
2)The patient that an own strength walk is possible
3)The patient who can list in an interview vote by oneself
4)the patient that agree the participation to this
5)The patient who meets the following clinical inspection standards
a) A hemoglobin level: >= 8.0 g/dl
b) A neutrophilic number: >= 1,000/mm3
c) The number of the platelets: >= 30,000/mm3
e) ALT and AST level: 6 times of the <= facilities standard
Key exclusion criteria
1) The patient who has an applicable heart trouble as follows
a) Congestive heart failures more than NYHA class 3
b) The high blood pressure that it is poor in control
2) Dangerously ill patient (except HBV, the HCV) who and has an infectious disease of the activity
3) Patient with a history of the HIV infection
4) Patient during hemodialysis
6) Patient of hepatic encephalopathy having difficulty in appropriate hydration
7) The patient who was treated whom patient 8) who produced the gastrointestinal tract bleeding that a blood transfusion and measures need within four weeks before this study start corresponds below to
a) Whole body chemotherapy within four weeks before this study start
b) The patient who has difficulty in 9 operation) drug remedy under the general anesthesia within four weeks before this study start
10) When may spoil the security of the patient in 13 patient) others affecting the evaluation of this study entry and result, this study enforcement or when the observance of this study enforcement plan is judged with difficulty by 12 patient) drug abuse that may wake up an allergic reaction for possibility of during a pregnant woman, the nursing and the pregnancy or this patient
11) study drug with the intention
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | IWASHITA |
| Middle name | |
| Last name | AI |
Organization
NIPPON MEDICAL SCHOOL HOSPITAL
Division name
gastroenterology
Zip code
113-0022
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3824-2332
a0520i@nms.ac.jp
Public contact
Name of contact person
| 1st name | IWASHITA |
| Middle name | |
| Last name | AI |
Organization
NIPPON MEDICAL SCHOOL HOSPITAL
Division name
gastroenterology
Zip code
113-0022
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL
03-3824-2332
Homepage URL
a0520i@nms.ac.jp
Sponsor or person
Institute
NIPPON MEDICAL SCHOOL HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NIPPON MEDICAL SCHOOL HOSPITAL
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel
03-3824-2332
a0520i@nms.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 04 | Month | 24 | Day |
Last modified on
| 2020 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041681
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