UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028637
Receipt number R000032776
Scientific Title Multicenter trial for the safety of rifaximin on hepatic encephalopathy
Date of disclosure of the study information 2018/01/01
Last modified on 2019/09/05 01:59:43

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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 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



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032776


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name