UMIN-CTR Clinical Trial

Basic information
Public title	Effect of ammonia-lowering therapy on covert hepatic encephalopathy: a prospective study
Acronym	Effect of ammonia-lowering therapy on covert hepatic encephalopathy: a prospective study
Scientific Title	Effect of ammonia-lowering therapy on covert hepatic encephalopathy: a prospective study
Scientific Title:Acronym	Effect of ammonia-lowering therapy on covert hepatic encephalopathy: a prospective study
Region	Japan

Condition
Condition	cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of ammonia-lowering therapy on covert hepatic encephalopathy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of covert hepatic encephalopathy
Key secondary outcomes

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	80 years-old >
Gender	Male and Female
Key inclusion criteria	cirrhotic patients with covert hepatic encephalopathy
Key exclusion criteria	Presence of overt hepatic encephalopathy or history of OHE in the past 4 weeks; Presence of uncontrolled hepatocellular carcinoma or other malignancies; Previous transjugular intrahepatic portosystemic shunt or shunt surgery; Active ongoing infection; History of gastrointestinal bleeding, infection or spontaneous bacterial peritonitis in the past 4 weeks; Drug or alcohol abuse in the past 4 weeks; Use of benzodiazepines, anti-epileptic or psychotropic drugs; Presence of neurological diseases; Pregnancy; Presence of severe comorbidities such as heart, respiratory, and/or renal failure
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Tatsunori Middle name Last name Hanai
Organization	Gifu University Graduate School of Medicine
Division name	Department of Gastroenterology/Internal Medicine
Zip code	5011194
Address	yanagido 1-1, gifu
TEL	058-230-6308
Email	hanai@gifu-u.ac.jp

Public contact
Name of contact person	1st name Tatsunori Middle name Last name Hanai
Organization	Gifu University Graduate School of Medicine
Division name	Department of Gastroenterology/Internal Medicine
Zip code	5011194
Address	yanagido 1-1, gifu
TEL	058-230-6308
Homepage URL
Email	hanai@gifu-u.ac.jp

Sponsor
Institute	Gifu University Graduate School of Medicine
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	ethics committee of Gifu University Graduate School of Medicine
Address	Yanagido 1-1 Gifu 501-1194
Tel	0582306059
Email	rinri@gifu-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

Other administrative information
Date of disclosure of the study information	2021 Year 08 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 04 Month 25 Day
Date of IRB
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2026 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 04 Month 25 Day
Last modified on	2021 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050281