UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012096 |
|---|---|
| Receipt number | R000014124 |
| Scientific Title | Efficacy of levocarnitine as an add-on treatment to branched-chain amino acid-enriched nutritional supplementation on liver cirrhosis complicated by hepatic encephalopathy -a open-label study |
| Date of disclosure of the study information | 2013/10/28 |
| Last modified on | 2015/04/23 15:33:00 |
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Basic information
Public title
Efficacy of levocarnitine as an add-on treatment to branched-chain amino acid-enriched nutritional supplementation on liver cirrhosis complicated by hepatic encephalopathy -a open-label study
Acronym
Efficacy of levocarnitine for hepatic encephalopathy
Scientific Title
Efficacy of levocarnitine as an add-on treatment to branched-chain amino acid-enriched nutritional supplementation on liver cirrhosis complicated by hepatic encephalopathy -a open-label study
Scientific Title:Acronym
Efficacy of levocarnitine for hepatic encephalopathy
Region
| Japan |
Condition
Condition
Liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of levocarnitine for hepatic encephalopathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of the symptoms caused by hyperammonemia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Oral administration of levocarnitine
Interventions/Control_2
No oral administration of levocarnitine
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) Past history of hepatic encephalopathy and latent hepatic encephalopathy
2) Hyperammonemia
3) Histologically proven or clinically diagnosed liver cirrhosis
4) Written informed consent
5) Patients should take levocarnitine for more than 3 months.
Key exclusion criteria
1) No administration of other test drugs within 3 months
2) No administration of other branched-chain amino acid enriched supplements
3) Severe concurrent disease
4) Pregnant and lactating females
5) Contraindication for levocarnitine and branched-chain amino acid enriched supplements
6) Inappropriate for entry onto this study in the judgment of the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunari Nakamoto |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Second Department of Internal Medicine
Zip code
Address
23-3 Matsuoka-shimoaitsuki, Eiheiji-cho, Fukui 910-1193, Japan
TEL
0776-61-8351
ynakamot@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Nemoto |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Second Department of Internal Medicine
Zip code
Address
23-3 Matsuoka-shimoaitsuki, Eiheiji-cho, Fukui 910-1193, Japan
TEL
0776-61-8351
Homepage URL
nemotot@u-fukui.ac.jp
Sponsor or person
Institute
Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medical Sciences, University of Fukui
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 10 | Month | 28 | 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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 21 | Day |
Last modified on
| 2015 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014124
