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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002707
Receipt No. R000003302
Scientific Title Anti-fibrotic activity of Irbesartan in chronic hepatitis with hypertension using Elastography
Date of disclosure of the study information 2009/11/11
Last modified on 2016/02/25

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Basic information
Public title Anti-fibrotic activity of Irbesartan in chronic hepatitis with hypertension using Elastography
Acronym Anti-fibrotic activity of Irbesartan
Scientific Title Anti-fibrotic activity of Irbesartan in chronic hepatitis with hypertension using Elastography
Scientific Title:Acronym Anti-fibrotic activity of Irbesartan
Region
Japan

Condition
Condition chronic hepatitis with hypertension
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To delay the progression to hepatic fibrosis is very important in hepatic diseases because it causes the progression to cirrhosis.
The objective of this study is to investigate the usefulness of hepatic fibrosis inhibition by Irbesartan (AvaproⓇ) with Elastography (Transient Elastography and Real-time Elastography), which is a noninvasive procedure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes liver fibrosis
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 Anti-fibrotic activity of Irbesartan
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 Chronic hepatitis
BP 140/90 mmHg <=
Key exclusion criteria 1. Patient is treated with RAS drugs prior to onset of this study.
2. Patient has a hepatocarcinoma.
3. Patient has a hypersensitivity to Irbesartan.
4. Patient is pregnant, or may become pregnant.
5. In the opinion of the investigator, patient is unsuitable as a study subject.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Morikawa
Organization Graduate School of Medicine
Osaka City University
Division name Department of Hepatology
Zip code
Address 1-4-3, Asahimachi, Abeno,Osaka JAPAN
TEL 06-6645-3801
Email morikawa-h@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyasu Morikawa
Organization Graduate School of Medicine, Osaka City University
Division name Department of Hepatology
Zip code
Address 1-4-3, Asahimachi, Abeno,Osaka
TEL 06-6645-3801
Homepage URL
Email morikawa-h@med.osaka-cu.ac.jp

Sponsor
Institute Graduate School of Medicine, Osaka City University
Institute
Department

Funding Source
Organization not funding
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 11 Month 11 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 No longer recruiting
Date of protocol fixation
2009 Year 09 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2013 Year 03 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 11 Month 04 Day
Last modified on
2016 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003302

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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