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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001670
Receipt No. R000002018
Scientific Title Effect of tranilast on liver pathology in patients with nonalcoholic fatty liver disease and allergic diseases
Date of disclosure of the study information 2009/01/30
Last modified on 2014/09/01

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Basic information
Public title Effect of tranilast on liver pathology in patients with nonalcoholic fatty liver disease and allergic diseases
Acronym Tranilast for treatment of nonalcoholic steatohepatitis
Scientific Title Effect of tranilast on liver pathology in patients with nonalcoholic fatty liver disease and allergic diseases
Scientific Title:Acronym Tranilast for treatment of nonalcoholic steatohepatitis
Region
Japan

Condition
Condition patients with nonalcoholic fatty liver
Classification by specialty
Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Liver histology of non nonalcoholic fatty liver
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Liver histology of non nonalcoholic fatty liver
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 Behavior,custom
Interventions/Control_1 tranilast
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 NAFLD
Key exclusion criteria HBV infection, HCV infection,
pregnancy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name yumie TAKESHITA
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Disease Control and Homeostasis
Zip code
Address 13-1 Takara-machi Kanazawa Ishikawa 920-8641 Japan
TEL 076-265-2233
Email

Public contact
Name of contact person
1st name
Middle name
Last name masafumi UNO
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Disease Control and Homeostasis
Zip code
Address 13-1 Takara-machi Kanazawa Ishikawa 920-8641 Japan
TEL 076-265-2233
Homepage URL
Email unomasa1977@yahoo.co.jp

Sponsor
Institute Kanazawa University Graduate School of Medical Science
Institute
Department

Funding Source
Organization Kanazawa University Graduate School of Medical Science
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 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
2009 Year 01 Month 30 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
2008 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2012 Year 07 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
2009 Year 01 Month 30 Day
Last modified on
2014 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002018

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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