UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044033 |
|---|---|
| Receipt number | R000050281 |
| Scientific Title | Effect of ammonia-lowering therapy on covert hepatic encephalopathy: a prospective study |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2021/04/25 15:27:06 |
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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
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
hanai@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
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
ethics committee of Gifu University Graduate School of Medicine
Address
Yanagido 1-1 Gifu 501-1194
Tel
0582306059
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050281
