UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009188 |
|---|---|
| Receipt number | R000010722 |
| Scientific Title | A pilot study of L-carnitine supplement for liver cirrhosis |
| Date of disclosure of the study information | 2012/10/25 |
| Last modified on | 2018/06/21 10:20:04 |
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Basic information
Public title
A pilot study of L-carnitine supplement for liver cirrhosis
Acronym
L-carnitine supplement for liver cirrhosis
Scientific Title
A pilot study of L-carnitine supplement for liver cirrhosis
Scientific Title:Acronym
L-carnitine supplement for liver cirrhosis
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 and safety of L-carnitine for patients with liver cirrhosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood ammonia levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of levocarnitine chloride
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) Histologically proven or clinically diagnosed liver cirrhosis
2) Hyperammonemia
3) Adequate organ function
4) Life expectancy of at least 3 months
5) Written informed consent
Key exclusion criteria
1) Severe hepatic encephalopathy
2) Refractory pleural effusion or ascites
3) Jaundice
4) Concurrent disease
a) Severe renal disease
b) Serious hypertension
c) Severe heart disease
d) Acute myocardial infarction within 6 months prior to inclusion
e) Active cancer
f) Severe mental disorder
g) Severe drug allergy
5) Pregnant and lactating females; females of childbearing age unless using effective contraception
6) Patients who are concluded to be inappropriate to participate in this study by their physicians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohichiroh Yasui |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2012 | Year | 10 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 26 | 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
| 2012 | Year | 10 | Month | 25 | Day |
Last modified on
| 2018 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010722
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
