UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032548
Receipt No. 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

* 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 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
Institute Nara Medical University
Institute
Department

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
URL(English) https://upload.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


Contact us.