UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032308 |
|---|---|
| Receipt number | R000036845 |
| Scientific Title | Efficacy of rifaximin for the treatment of hepatic encephalopathy through the intestinal permeability: an open-label, single-arm, singlecenter, pilot study |
| Date of disclosure of the study information | 2018/04/18 |
| Last modified on | 2018/04/18 22:10:38 |
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Basic information
Public title
Efficacy of rifaximin for the treatment of hepatic encephalopathy through the intestinal permeability: an open-label, single-arm, singlecenter, pilot study
Acronym
Efficacy of rifaximin for the treatment of hepatic encephalopathy through the intestinal permeability
Scientific Title
Efficacy of rifaximin for the treatment of hepatic encephalopathy through the intestinal permeability: an open-label, single-arm, singlecenter, pilot study
Scientific Title:Acronym
Efficacy of rifaximin for the treatment of hepatic encephalopathy through the intestinal permeability
Region
| Japan |
Condition
Condition
hepatic encephalopathy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate efficacy of rifaximine for the treatment of minimal hepatic encephalopathy and Hepatic encephalopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change from a baseline of blood endotoxin activity in four weeks.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subjects are administered 400mg of rifaximine once orally after meal three times a day. They take medicine after registration for 28 days.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient who had a diagnosis of cirrhosis by pathology or diagnostic imaging.
The patient have minimal hepatic encephalopathy or hepatic encephalopathy.
The patient that treatment does not have the change for three months.
Key exclusion criteria
The patient with the change of the medicine for the hepatic encephalopathy within agreement acquisition three months ago.
The patient who corresponds to a taboo listed in the attached document of rifaximine.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Honda Yasushi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
Yokohama, Japan
TEL
045-787-2640
y-honda@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Honda Yasushi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
Yokohama, Japan
TEL
045-787-2640
Homepage URL
y-honda@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan
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
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 | 04 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 15 | 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 | 04 | Month | 18 | Day |
Last modified on
| 2018 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036845
