UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001266 |
|---|---|
| Receipt number | R000001541 |
| Scientific Title | Therapeutic efficacy of ezetimibe for use minute lipid analyzer: LipoSEARCH in patients with nonalcoholic steatohepatitis (NASH) complicated with hyperlipidemia: a pilot study. |
| Date of disclosure of the study information | 2008/07/25 |
| Last modified on | 2008/07/24 11:10:13 |
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Basic information
Public title
Therapeutic efficacy of ezetimibe for use minute lipid analyzer: LipoSEARCH in patients with nonalcoholic steatohepatitis (NASH) complicated with hyperlipidemia: a pilot study.
Acronym
Efficacy of ezetimibe in NASH patients
Scientific Title
Therapeutic efficacy of ezetimibe for use minute lipid analyzer: LipoSEARCH in patients with nonalcoholic steatohepatitis (NASH) complicated with hyperlipidemia: a pilot study.
Scientific Title:Acronym
Efficacy of ezetimibe in NASH patients
Region
| Japan |
Condition
Condition
Nonalcoholic steatohepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of ezetimibe compared liver lipid-metabolite alteration with histologic improvement in subjects with nonalcoholic steatohepatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Before and after 6 months of ezetimibe (10mg daily) to nonalcoholic statohepatitis (NASH) patients, we assessed liver lipid-metabolite alteration for use minute lipid analyzer: LipoSEARCH.
Key secondary outcomes
we compared with hepatic histologic features,
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of ezetimibe (10mg daily) in 24 weeks.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a. All patients complicate hyperlipidemia (LDL-cholesterol >140, or Triacylglycerol >150)
b. The biopsy-proven nonalcoholic steatosis (NASH) patient will be evaluated in this study.
c. All patients gave their written informed consent to participation in the study.
Key exclusion criteria
a.The criteria for exclusion from participation in the study: history of hepatic disease, such as chronic hepatitis C or concurrent active hepatitis B (serum positive for hepatitis B surface antigen), autoimmune hepatitis, primary biliary cirrhosis (PBC), sclerosing cholangitis, hemochromatosis, alpha1-antitrypsin deficiency, Wilsons disease, and current or past consumption of more than 20 g of alcohol daily.
b. None of the patients had any clinical evidence of hepatic decompensation, such as hepatic encephalopathy, ascites, variceal bleeding, or elevated serum bilirubin level to more than twofold the upper limit of normal.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama-city university hospital
Division name
Division of Gastroenterology
Zip code
Address
3-9,fukuura,kanazawa-ku,yokohama,kanagawa,Japan
TEL
045-787-2640
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Fujita |
Organization
Yokohama-city university hospital
Division name
Division of Gastroenterology
Zip code
Address
3-9,fukuura,kanazawa-ku,yokohama,kanagawa,Japan
TEL
045-787-2640
Homepage URL
kfujita@yokohama-cu.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant from Ministry of Education, Science, Sports and Culture in Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2008 | Year | 07 | 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
Date of protocol fixation
| 2008 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | 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
| 2008 | Year | 07 | Month | 24 | Day |
Last modified on
| 2008 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001541
