UMIN-CTR Clinical Trial

Basic information
Public title	The trial for effect of RFX on hepatic encepalopathy
Acronym	The study of the effect of RFX
Scientific Title	The trial for effect of RFX on hepatic encepalopathy
Scientific Title:Acronym	The study of the effect of RFX
Region	Japan

Condition
Condition	hepatic encephalopathy
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	We investigate the effect of RFX on HE
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Improvment of HE 2.Improvment of the intestinal becterial flora
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)>20 years old 2)The patients obtained the consent 3)>4 weeks of suvival periods 4)AST and ALT > 6 times from the facilities standards
Key exclusion criteria	1)The impossible of oral intake 2)The pharmacokinetics in changed for patient's condition 3)The necessary medicine change the pharmacokinetics of rifaximin 4)The pregnancy and lactaing 5)The allergy of rifaximin 6)The outcome evaluation is difficult for patient's condition 7)The execution plan of achievement is difficult
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Hiroaki
Organization	Nara medical unversity
Division name	3rd department of interanal medicine
Zip code	6348521
Address	840,Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Email	htky@naramed-u.ac.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Hiroaki Takaya
Organization	Nara medical unversity
Division name	3rd department of interanal medicine
Zip code	6348521
Address	840,Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Homepage URL
Email	htky@naramed-u.ac.jp

Sponsor
Institute	Nara medical University
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nara medical university
Address	840,Shijo-cho, Kashihara, Nara
Tel	0744223051
Email	htky@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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 13 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	2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing

Management information
Registered date	2017 Year 09 Month 13 Day
Last modified on	2019 Year 11 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033306