UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter trial for the safety of rifaximin on hepatic encephalopathy
Acronym	The study of the safety of rifaximin
Scientific Title	Multicenter trial for the safety of rifaximin on hepatic encephalopathy
Scientific Title:Acronym	The study of the safety of rifaximin
Region	Japan

Condition
Condition	hepatic encephalopathy
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety of rifaximin on hepatic encephalopathy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Long-term safety.
Key secondary outcomes	Improvement of hepatic encephalopathy Depression of occurrence

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)> 12 months of suvival periods 4) a)Child Pugh score <=9 b)T-Bil <5.0 mg/dL c)AST and ALT <=6 times of the facilities standards
Key exclusion criteria	1)The impossible of oral intake 2)The pharmacokinetics is changed for patient's condition 3)The necessary medicine change the pharmacokinetics of rifaximin 4)The pregnancy and lactating 5)The allergy of rifaximin 6)The outcome evaluation is difficult for patient's condition 7)Suffering hepatoma 8)The execution plan of achievement is difficult
Target sample size	150

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

Public contact
Name of contact person	1st name Kosuke Middle name Last name Kaji
Organization	Nara medical unversity
Division name	3rd departemnt of interanal medicine
Zip code	6348521
Address	840, Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Homepage URL
Email	kajik@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

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

IRB Contact (For public release)
Organization	Nara medical unversity, IRB
Address	840, Shijo-cho, Kashihara, Nara
Tel	81744223051
Email	ino_rinri@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	2018 Year 01 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	Enrolling by invitation
Date of protocol fixation	2017 Year 07 Month 10 Day
Date of IRB	2018 Year 03 Month 19 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2026 Year 03 Month 31 Day

Other
Other related information	nothing

Management information
Registered date	2017 Year 08 Month 11 Day
Last modified on	2019 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032776