UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029127
Receipt number R000033306
Scientific Title The trial for effect of RFX on hepatic encepalopathy
Date of disclosure of the study information 2017/09/13
Last modified on 2019/11/29 20:30:55

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Nara medical University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033306


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name