UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050125 |
|---|---|
| Receipt number | R000056039 |
| Scientific Title | Studies on the Efficacy of rifaximin for covert hepatic encephalopathy |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2024/01/26 09:39:54 |
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Basic information
Public title
Studies on the Efficacy of rifaximin for covert hepatic encephalopathy
Acronym
Rifaximin study
Scientific Title
Studies on the Efficacy of rifaximin for covert hepatic encephalopathy
Scientific Title:Acronym
Rifaximin study
Region
| Japan |
Condition
Condition
Covert hepatic encephalopathy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Studies on the Efficacy of Rifaximin for covert hepatic encephalopathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of stroop test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rifaximin
Interventions/Control_2
No treatment
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with cirrhosis. However, even if it is not cirrhosis, patients with portal vein general circulation short circuit can participate.
2. Japan patients whose age at the time of obtaining consent is 20 years of age or older and under 75 years of age.
3. Patients who have received a thorough explanation of the content of their research and obtained their written consent. However, if the attending physician determines that it is difficult to obtain consent due to the lack of consent ability of the person who should be the subject, etc., the applicant may participate in this study by obtaining the written consent of the substitute in addition to the written consent of the subject himself/herself.
4. Patients who can be hospitalized or visited at the necessary time during the research period.
5. The presence or absence of administration of synthetic disaccharides is not required.
6. The level of ammonia in the blood does not matter.
Key exclusion criteria
1. Patients with a mental illness (depression, mask depression, schizophrenia, dementia, etc.)
2. Patients diagnosed with malignant tumors and are undergoing treatment or untreated
3. Patients who have any of the following complications:
Ascites requiring regular drainage
Bleeding due to rupture of esophagus and gastric varicose veins
Idiopathic bacterial peritonitis
Severe electrolyte abnormalities that affect neuropsychiatric function
4. Patients with a history of hypersensitivity to rifaximin
5. Have serious complications listed below
Patients with severe renal impairment or end-stage renal failure under dialysis
Patients with uncontrolled conditions such as myocardial infarction, heart failure, angina pectoris, and arrhythmia
6. If a carnitine or zinc preparation is newly administered or the dose is changed between 4 weeks before the administration of rifaximin and 12 weeks after administration.
7. Pregnant women, lactating patients, and patients who may or intend to become pregnant
8. Patients with difficulty taking it orally
9. Other patients that the physician deems inappropriate to safely conduct this study
10. Patients with concomitant use of the following drugs (prohibited drugs: ethinylestradiol, cyclosporine).
11. Patients who have started antibiotics containing rifaximin or proton pump inhibitors within 12 weeks.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuhito |
| Middle name | |
| Last name | Tanaka |
Organization
Kumamoto University
Division name
Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences.
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
TEL
0963735150
ytanaka@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Inada |
Organization
Kumamoto University
Division name
Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences.
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
TEL
0963735150
Homepage URL
inada.hiroki@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Human Ethics Review Committee of Kumamoto University
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
Tel
0963735657
byi-senshin@jimu.kumamoto-u.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
熊本大学病院（熊本県）、北里大学病院（神奈川県）、手稲渓仁会病院（北海道）、愛媛県立中央病院（愛媛県）、長崎大学病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 01 | 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
| 2023 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056039
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
