UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028637 |
|---|---|
| Receipt number | R000032776 |
| Scientific Title | Multicenter trial for the safety of rifaximin on hepatic encephalopathy |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2019/09/05 01:59:43 |
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Basic information
Public title
Multicenter trial for the safety of rifaximin on hepatic encephalopathy
Acronym
The study of the safety of rifaximin
Scientific Title
Multicenter trial for the safety of rifaximin on hepatic encephalopathy
Scientific Title:Acronym
The study of the safety of rifaximin
Region
| Japan |
Condition
Condition
hepatic encephalopathy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of rifaximin on hepatic encephalopathy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Long-term safety.
Key secondary outcomes
Improvement of hepatic encephalopathy
Depression of occurrence
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)> 12 months of suvival periods
4)
a)Child Pugh score <=9
b)T-Bil <5.0 mg/dL
c)AST and ALT <=6 times of the facilities standards
Key exclusion criteria
1)The impossible of oral intake
2)The pharmacokinetics is changed for patient's condition
3)The necessary medicine change the pharmacokinetics of rifaximin
4)The pregnancy and lactating
5)The allergy of rifaximin
6)The outcome evaluation is difficult for patient's condition
7)Suffering hepatoma
8)The execution plan of achievement is difficult
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Yoshiji |
Organization
Nara medical unversity
Division name
3rd departemnt of interanal medicine
Zip code
6348521
Address
840, Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
3naika@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Kaji |
Organization
Nara medical unversity
Division name
3rd departemnt of interanal medicine
Zip code
6348521
Address
840, Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
kajik@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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara medical unversity, IRB
Address
840, Shijo-cho, Kashihara, Nara
Tel
81744223051
ino_rinri@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
| 2018 | Year | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
nothing
Management information
Registered date
| 2017 | Year | 08 | Month | 11 | Day |
Last modified on
| 2019 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032776
