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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044146
Receipt No. R000050398
Scientific Title Study on the effect of rifaximin on cirrhosis
Date of disclosure of the study information 2021/05/10
Last modified on 2021/05/08

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Basic information
Public title Study on the effect of rifaximin on cirrhosis
Acronym Rifaximin in cirrhosis
Scientific Title Study on the effect of rifaximin on cirrhosis
Scientific Title:Acronym Rifaximin in cirrhosis
Region
Japan

Condition
Condition Hepatic encephalopathy (Overt encephalopathy, Covert encephalopathy)
Hyperammonemia
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the usefulness and efficacy predictors of rifaximin in cases of liver cirrhosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in ammonia levels due to rifaximin administration
Key secondary outcomes 1.Changes in hepatic encephalopathy symptoms before and after administration of rifaximin
2.Changes in NP-test test results before and after administration of rifaximin
3.Changes in bacterial translocation markers before and after administration of rifaximin
4.Changes in muscle mass before and after administration of rifaximin
5.Changes in fecal bacterial flora before and after administration of rifaximin
6.Correlation between ammonia value, various blood test values, and NP-test results
7.Correlation between ammonia value and bacterial translocation marker
8.Correlation between ammonia level and endotoxin and preceptin
9.Relationship between ammonia level and fecal bacterial flora

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.Those who are 20 years old or older at the time of obtaining consent
2. Liver disease patients with hyperammonemia (70 g / dl or more)
3. Those who have voluntarily consented to participate in this study
Key exclusion criteria 1.Persons with pulmonary tuberculosis and other tuberculosis
2.Those who are pregnant or breastfeeding
3.Those who have been diagnosed with pseudomembranous enteritis
4.Others who are judged by the principal investigator or coordinator to be inappropriate as research subjects
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Nakai
Organization Hokkaido University Hospital
Division name Gastroenterology and Hepatology
Zip code 0608638
Address Kita-15, Nishi-7, Kita-ku,Sapporo,Hokkaido
TEL 0117161161
Email mnakai@pop.med.hokudai.ac.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Nakai
Organization Hokkaido University Hospital
Division name Gastroenterology and Hepatology
Zip code 0608638
Address Kita-15, Nishi-7, Kita-ku,Sapporo,Hokkaido
TEL 0117161161
Homepage URL
Email mnakai@pop.med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

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 Hokkaido University Hospital Division of Clinical Research Administration
Address Kita-15, Nishi-7, Kita-ku, Sapporo, Hokkaido
Tel 0117067636
Email crjimu@huhp.hokudai.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
2021 Year 05 Month 10 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
2018 Year 01 Month 30 Day
Date of IRB
2018 Year 02 Month 02 Day
Anticipated trial start date
2018 Year 02 Month 05 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2023 Year 06 Month 30 Day
Date analysis concluded

Other
Other related information None

Management information
Registered date
2021 Year 05 Month 08 Day
Last modified on
2021 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050398

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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