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
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
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
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
