UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044657 |
|---|---|
| Receipt number | R000050332 |
| Scientific Title | Efficacy and safety of Rifaximin for the treatment of liver cirrhosis with covert hepatic encephalopathy |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2023/12/27 09:55:13 |
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Basic information
Public title
Efficacy and safety of Rifaximin for the treatment of liver cirrhosis with covert hepatic encephalopathy
Acronym
Covert encephalopathy and Rifaximin
Scientific Title
Efficacy and safety of Rifaximin for the treatment of liver cirrhosis with covert hepatic encephalopathy
Scientific Title:Acronym
Covert encephalopathy and Rifaximin
Region
| Japan |
Condition
Condition
Liver cirrhosis
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the efficacy of rifaximin in the treatment of liver cirrhosis with covert hepatic encephalopathy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The purpose of this study is to evaluate the efficacy of the Number connection test-A in improving liver cirrhosis with covert hepatic encephalopathy. Patients will be evaluated before, 4 weeks after, 8 weeks after, and 12 weeks after rifaximin administration.
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
The study subjects will be orally administered 400 mg of rifaximin three times a day after each meal. The administration period will be 12 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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as liver cirrhosis (one of the following is recognized)
1) Diagnosed as liver cirrhosis by liver biopsy
2) Imaging findings typical of liver cirrhosis (irregularity of the liver surface, blunting of the margins, presence of uneven, coarse, or regenerated nodules in the liver parenchyma, findings of portal hypertension such as splenomegaly, dilatation of the splenic veins, and collateral blood vessels, and changes in the shape of the liver such as atrophy of the right lobe of the liver, atrophy of the medial zone of the liver, and enlargement of the lateral zone)
3) Typical endoscopic findings (esophagogastric varices, portal hypertensive gastropathy, etc.)
4) Platelet count of 150,000/mm3 or less
5) Vs measured by Virtual Touch Tissue Quantification (VTTQ) is 1.75 m/s or more, or Vs measured by Shear Wave Measurement (SWM) is 1.617 m/s or more.
6) APRI is greater than or equal to 1.
2. Hyperammonemia is present.
3. Without overt hepatic encephalopathy, and being diagnosed as covert hepatic encephalopathy by neuropsychiatric function tests (Number connection test-A and B, Stroop test)
4. Patients aged 40 years or older but less than 80 years at the time of consent.
5. Patient's written consent has been obtained.
Key exclusion criteria
1. Patients who are not in a clear state of consciousness
2. Patients with psychiatric disorders (depression, masked depression, schizophrenia, dementia, etc.)
3. Patients with malignant tumors including hepatocellular carcinoma
4. Patients with any of the following complications
1) Ascites requiring periodic drainage
2) Bleeding due to rupture of esophageal or gastric varices
3) Spontaneous bacterial peritonitis
4) Severe electrolyte abnormalities that may affect neuropsychiatric function
5. Patients with a history of hypersensitivity to rifaximin
6. Patients with the following serious complications
1) Patients with severe renal dysfunction or end-stage renal failure on dialysis
2) Patients with poorly controlled myocardial infarction, heart failure, angina pectoris, arrhythmia, etc.
7. New administration or change in dosage of synthetic disaccharides, carnitine, zinc, or laxatives between 4 weeks before and 12 weeks after administration of rifaximin
8. Pregnant women, lactating women, and patients who may or intend to become pregnant
9. Patients who have difficulty in oral intake
10. Other patients who are deemed by the physician to be inappropriate for the safe conduct of this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama Medical University
Division name
Department of Gastroenterology
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama City
TEL
073-441-0627
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shiori |
| Middle name | |
| Last name | Kaji |
Organization
Wakayama Medical University
Division name
Department of Gastroenterology
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama City
TEL
073-441-0627
Homepage URL
s.kaji@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Wakayama Medical University Research Ethics Committee
Address
811-1 Kimiidera, Wakayama City
Tel
073-447-2300
wa-rinri@wakayama-med.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 | 07 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2021 | Year | 06 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050332
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