UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038487 |
|---|---|
| Receipt number | R000043845 |
| Scientific Title | USE OF RIFAXIMIN THERAPY IN PRIMARY PREVENTION OF HEPATORENAL SYNDROME IN CIRRHOTIC PATIENTS WITH ASCITES |
| Date of disclosure of the study information | 2019/11/03 |
| Last modified on | 2019/11/03 21:35:36 |
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Basic information
Public title
USE OF RIFAXIMIN THERAPY IN PRIMARY PREVENTION OF HEPATORENAL SYNDROME IN CIRRHOTIC PATIENTS WITH ASCITES
Acronym
USE OF RIFAXIMIN THERAPY IN PRIMARY PREVENTION OF HEPATORENAL SYNDROME IN CIRRHOTIC PATIENTS WITH ASCITES
Scientific Title
USE OF RIFAXIMIN THERAPY IN PRIMARY PREVENTION OF HEPATORENAL SYNDROME IN CIRRHOTIC PATIENTS WITH ASCITES
Scientific Title:Acronym
USE OF RIFAXIMIN THERAPY IN PRIMARY PREVENTION OF HEPATORENAL SYNDROME IN CIRRHOTIC PATIENTS WITH ASCITES
Region
| Asia(except Japan) |
Condition
Condition
Liver Cirrhosis with ascites
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see incidence of Hepatorenal syndrome in rifaximin group vs control group.
Basic objectives2
Others
Basic objectives -Others
To see renal function test (i.e. urea and creatinine ) in rifaxamin group and control group
at baseline , 4 week, 8 week & 12 week.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of hepatorenal syndrome within 12 weeks.
Key secondary outcomes
Change in urea and creatinine level at 4 week,8week and 12 week.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Rifaximin group ,Tab rifaximin at a dose of 550mg BD for 12 weeks and other
standard treatment.
Interventions/Control_2
Non Rifaximin group,Only standar Rx.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Age of the patients to be above 18 yrs .
2.Diagnosis of liver cirrhosis and documented ascites.
3.Child-Pugh score of 7 or more
Key exclusion criteria
1. Patients with renal impairment (serum creatinine>1.5mg/dl)
2. History of HRS, nephropathy and obstructive Uropathy
3. Recent exposure to radioactive materials and Nephrotoxic drugs
4. Sepsis
5. Hepatocellular carcinoma
6. History of allergic reaction with rifaxmin.
Target sample size
94
Research contact person
Name of lead principal investigator
| 1st name | Sanjit |
| Middle name | |
| Last name | Karki |
Organization
Patan Academy of health sciences,Patan Hospital.
Division name
Medicine,Gastroenterology
Zip code
44600
Address
.Lagankhel,lalitpur,Nepal
TEL
9841277196
sanjitkarki@pahs.edu.np
Public contact
Name of contact person
| 1st name | Sanjit |
| Middle name | |
| Last name | Karki |
Organization
Patan Academy of Health sciences
Division name
Medicine,Gastrenterology
Zip code
44600
Address
Lagankhel,lalitpur,Nepal
TEL
9841277196
Homepage URL
sanjitkarki@pahs.edu.np
Sponsor or person
Institute
NationalAcademy of health Sciences,Bir Hospital
Department Of Medicine
Gastroenterology Unit
Institute
Department
Personal name
Funding Source
Organization
NationalAcademy of health Sciences,Bir Hospital
Department Of Medicine
Gastroenterology Unit
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Academy of medical sciences
Address
Mahaboudha,Kathmandu,Nepal
Tel
+977-1-4230710
admin@nams.org.np
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
| 2019 | Year | 11 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 03 | Day |
Last modified on
| 2019 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043845
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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