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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001266
Receipt No. 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

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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
Email

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
Email kfujita@yokohama-cu.ac.jp

Sponsor
Institute Division of Gastroenterology, Yokohama City University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001541

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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