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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044657
Receipt No. 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 2021/06/25

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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
Email 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
Email s.kaji@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2021 Year 08 Month 01 Day
Last follow-up date
2024 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
2021 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050332

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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