UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029127 |
|---|---|
| Receipt number | R000033306 |
| Scientific Title | The trial for effect of RFX on hepatic encepalopathy |
| Date of disclosure of the study information | 2017/09/13 |
| Last modified on | 2019/11/29 20:30:55 |
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Basic information
Public title
The trial for effect of RFX on hepatic encepalopathy
Acronym
The study of the effect of RFX
Scientific Title
The trial for effect of RFX on hepatic encepalopathy
Scientific Title:Acronym
The study of the effect of RFX
Region
| Japan |
Condition
Condition
hepatic encephalopathy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We investigate the effect of RFX on HE
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Improvment of HE
2.Improvment of the intestinal becterial flora
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)>20 years old
2)The patients obtained the consent
3)>4 weeks of suvival periods
4)AST and ALT > 6 times from the facilities standards
Key exclusion criteria
1)The impossible of oral intake
2)The pharmacokinetics in changed for patient's condition
3)The necessary medicine change the pharmacokinetics of rifaximin
4)The pregnancy and lactaing
5)The allergy of rifaximin
6)The outcome evaluation is difficult for patient's condition
7)The execution plan of achievement is difficult
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Hiroaki |
Organization
Nara medical unversity
Division name
3rd department of interanal medicine
Zip code
6348521
Address
840,Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
htky@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Hiroaki Takaya |
Organization
Nara medical unversity
Division name
3rd department of interanal medicine
Zip code
6348521
Address
840,Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
htky@naramed-u.ac.jp
Sponsor or person
Institute
Nara medical University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara medical university
Address
840,Shijo-cho, Kashihara, Nara
Tel
0744223051
htky@naramed-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
| 2017 | Year | 09 | Month | 13 | 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
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2017 | Year | 09 | Month | 13 | Day |
Last modified on
| 2019 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033306
