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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009133
Receipt No. R000010696
Scientific Title The Effect of Levocarnitine on the Patient with Non-alcoholic Fatty Liver Disease
Date of disclosure of the study information 2012/10/17
Last modified on 2020/10/22

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Basic information
Public title The Effect of Levocarnitine on the Patient with Non-alcoholic Fatty Liver Disease
Acronym Levocarnitine for Treatment of Non-alcoholic Fatty Liver Disease
Scientific Title The Effect of Levocarnitine on the Patient with Non-alcoholic Fatty Liver Disease
Scientific Title:Acronym Levocarnitine for Treatment of Non-alcoholic Fatty Liver Disease
Region
Japan

Condition
Condition Non-Alcoholic Fatty Liver Disease (NAFLD)
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Several study have suggested that Levocarnitine is related to transportation of Fatty acid into mitochondria and the fat deposit to hepatocyte. However, no studies have been done to research the effect and mechanism of Levocarnitine on Non-Alcoholic Fatty Liver Disease(NAFLD).
Thus, the aim of this study is to research the efficacy and safety of Levocarnitine on the patient with NAFLD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of serum ALT after taking Levocarnitine for 6 months
Key secondary outcomes The following items are assessed after taking Levocarnitine for 6 months
1. Safety
2. Improvement of metabolic disorder
3. Improvement of histological findings of the liver
4. the effect of Levocarnitine on the gene expression(mRNA)
5. The effect of Levocarnitine on immunoreaction in the liver
6. The concentration of the Levocarnitine and the effect of Levocarnitine on fatty acid composition in the liver


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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 Levocarnitine at a 600mg thrice daily for 6months
Interventions/Control_2 control
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
80 years-old >
Gender Male and Female
Key inclusion criteria Subjects who are
1. Diagnosed as NAFLD by histological examination.
2. Tolerable to take Levocarnicine for 6 month.
3. Child-Pugh classification A.
4. Age order than or equal to 20years old and younger than 80 yaers old at time of the consent.
5. Performance status(ECOG scale) 0 or 1.
6. The function of main organs should should be well maintained within 14 days before time of the consent.
6-1, WBC;greater than or equal to 3,000 and less than 12,000/uL
6-2, Hb;greater than or equal to 9.0g/dL
6-3, Platelet;greater than or equal to 70,000/uL
6-4, Total Bilirubin;less than or equal to 1.5mg/dL or lower than upper limit of the facility
6-5, Serum ALT;greater than upper limit of the facility and less than or equal to 300 U/L
6-6, Serum Cr;less than or equal to 1.2mg/dL or lower than upper limit of the facility
6-7, The patients have to agree to join this study by their free wills
Key exclusion criteria The following patients should be excluded
1. Infected with HBV or HCV
2. Alcohol assumption per day; greater than 20g
3. Complicated with malignant disease including hepatocellular carcinoma
4. Complicated with obvious hepatic encephalopathy
5. Complicated with active infectious disease
6. Complicated with Critical complications
7. Nursing and Pregnant woman
8. Taking contraindicating medicines with Levocarnitine
9. Taking pioglitazone and metformin
10.the other patients who the doctors in charge consider should not enter this study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Sunagozaka
Organization kanazawa University Hospital
Division name Department of Gastroenterology
Zip code
Address 13-1, takaramachi, Kanazawa, Ishikawa
TEL 076-265-2235
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Sunagozaka
Organization kanazawa University Hospital
Division name Department of Gastroenterology
Zip code
Address 13-1, takaramachi, Kanazawa, Ishikawa
TEL 076-265-2235
Homepage URL
Email suna@m-kanazawa.jp

Sponsor
Institute Kanazawa University Graduate School of Medical Science, Disease Contral and Homeostasis
Institute
Department

Funding Source
Organization Kanazawa University Graduate School of Medical Science, Disease Contral and Homeostasis
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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 5782
Org. issuing International ID_1 Knazawa University Hospital, Center for Clinical Research Management
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 17 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
2012 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 09 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
2012 Year 10 Month 17 Day
Last modified on
2020 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010696

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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