UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016672 |
|---|---|
| Receipt number | R000019224 |
| Scientific Title | Efficacy and safty of high dose blood purification for hepatic encephalopathy by acute liver failure and fluminant hepatitis |
| Date of disclosure of the study information | 2015/10/16 |
| Last modified on | 2016/11/06 18:29:09 |
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Basic information
Public title
Efficacy and safty of high dose blood purification for hepatic encephalopathy by acute liver failure and fluminant hepatitis
Acronym
Efficacy and safty of high dose blood purification for hepatic encephalopathy
Scientific Title
Efficacy and safty of high dose blood purification for hepatic encephalopathy by acute liver failure and fluminant hepatitis
Scientific Title:Acronym
Efficacy and safty of high dose blood purification for hepatic encephalopathy
Region
| Japan |
Condition
Condition
hepatic encephalopathy
Classification by specialty
| Hepato-biliary-pancreatic medicine | Nephrology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safty of high dose blood purification for controlling hepatic encephalopathy by acute hapatic failure and fluminant hepatitis toward liver transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
progression-free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
High dose blood purification by
on-line HDF and/or high flow - high volume CHDF
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
1. Hepatic encephalopathy by acute hepatic failure or fluminant hepatitis
2. Candidate of recipient of liver transplantation
3. Written agreement after informed consent
Key exclusion criteria
1. Postoperative liver failure without liver transplantation
2. Dinied liver transplantation
3. Unccontrolled gastrointestinal bleeding
4. Unconsciousnes by other causes
5. Improper patients
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuo Tsukamoto |
Organization
Kyoto Unversity Hospital
Division name
Nephrology
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3860
ttsukamo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Tsukamoto |
Organization
Kyoto University Hospital
Division name
Nephrology
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3860
Homepage URL
ttsukamo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Nephrology, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 31 | 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 | 03 | Month | 01 | Day |
Last modified on
| 2016 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019224
| Research Plan | |
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| Registered date | File name |
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