UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safty of high dose blood purification for hepatic encephalopathy by acute liver failure and fluminant hepatitis
Title of the study (Brief title)	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	Tatsuo Tsukamoto
Organization	Kyoto Unversity Hospital
Division name	Nephrology
Address	54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3860
Email	ttsukamo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Tatsuo Tsukamoto
Organization	Kyoto University Hospital
Division name	Nephrology
Address	54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3860
Homepage URL
Email	ttsukamo@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Nephrology, Kyoto University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019224