UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027511 |
|---|---|
| Receipt number | R000031535 |
| Scientific Title | Combination therapy with levocarnitine and rifaximin for hepatic encephalopathy in patients with cirrhosis: a randomized study |
| Date of disclosure of the study information | 2017/06/07 |
| Last modified on | 2021/07/20 19:50:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Combination therapy with levocarnitine and rifaximin for hepatic encephalopathy in patients with cirrhosis: a randomized study
Acronym
Combination therapy with levocarnitine and rifaximin for liver encepharopaty
Scientific Title
Combination therapy with levocarnitine and rifaximin for hepatic encephalopathy in patients with cirrhosis: a randomized study
Scientific Title:Acronym
Combination therapy with levocarnitine and rifaximin for liver encepharopaty
Region
| Japan |
Condition
Condition
hepatic encephalopathy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of combination therapy with levocarnitine and rifaximin for hepatic encephalopathy in patients with cirrhosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood ammonia concentration
Key secondary outcomes
(1) PSE score
(2) Number connection test-A
(3) Number connection test-B
(4) Quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination therapy with levocarnitine and rifaximin
Interventions/Control_2
Monotherapy with rifaximin
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 Hepatic encephalopathy
Positive of number conection test A
Grade 1 West Haven criteria
Serum ammonia more than 80ug/dL
2 Liver cirrhosis
3 Carnitine deficiency
4 Informed consent was obtained
Key exclusion criteria
1 Psychiatric disorder which is uncontrolled
2 Acute liver failure
3 Rapture of esophagus varices
4 Spontaneous bacterial peritonitis
5 Laboratory abnormalities
-T-bil>5.0mg/dL
-Cre>2.0mg/dL
-Hb <8.0g/dL
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
2530822
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
TEL
042-778-8390
kiruha@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
2530822
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
TEL
042-778-8390
Homepage URL
kiruha@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
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
kitasato university Institutional Review Board
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
Tel
042-778-8390
rinrib@med.kitasato-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 | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
83
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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 28 | Day |
Last modified on
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031535
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
