UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044146 |
|---|---|
| Receipt number | R000050398 |
| Scientific Title | Study on the effect of rifaximin on cirrhosis |
| Date of disclosure of the study information | 2021/05/10 |
| Last modified on | 2022/09/09 20:06:51 |
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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
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
mnakai@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
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
Hokkaido University Hospital Division of Clinical Research Administration
Address
Kita-15, Nishi-7, Kita-ku, Sapporo, Hokkaido
Tel
0117067636
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
Main results already published
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
| 2022 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050398
