UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032548
Receipt number R000037121
Scientific Title The effect of rifaximin on liver cirrhosis patients with hepatic encephalopathy
Date of disclosure of the study information 2018/05/11
Last modified on 2018/05/10 19:30:55

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Basic information

Public title

The effect of rifaximin on liver cirrhosis patients with hepatic encephalopathy

Acronym

The effect of rifaximin on liver cirrhosis patients with hepatic encephalopathy

Scientific Title

The effect of rifaximin on liver cirrhosis patients with hepatic encephalopathy

Scientific Title:Acronym

The effect of rifaximin on liver cirrhosis patients with hepatic encephalopathy

Region

Japan


Condition

Condition

liver cirrhosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examine the effect of rifaximin in patients with cirrhosis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Effectiveness to hepatic encephalopathy (serum ammonia value, endotoxin activity)

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Rifaximin 400 mg administered three times a day for 4 weeks.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The subjects are patients with decompensated cirrhosis due to several causes, aged 18 years or older, who have been diagnosed by clinical, biochemical, and ultrasound findings.

Key exclusion criteria

The exclusion criteria are cardiac and/or respiratory failure or invasive cancer within the past 5 years; renal failure; clinical or biochemical signs of infection 28 d prior to inclusion; concomitant inflammatory bowel diseases and/or irritable bowel syndrome; previous history of gastrectomy, enterectomy, and/or liver transplantation; and developed portosystemic shunt. Patients who consume nonabsorbable disaccharides, probiotics, prebiotics, synbiotics, or other antibiotics 28 days prior to inclusion are also excluded.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kosuke Kaji

Organization

Nara Medical University

Division name

Third Department of Internal Medicine

Zip code


Address

840 Shijo-cho, Kashihara, Nara

TEL

0744-22-3051

Email

kajik@naramed-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kosuke Kaji

Organization

Nara Medical University

Division name

Third Department of Internal Medicine

Zip code


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

Nara Medical University

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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 05 Month 11 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

No longer recruiting

Date of protocol fixation

2017 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 04 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



Management information

Registered date

2018 Year 05 Month 10 Day

Last modified on

2018 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037121


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name