UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002707 |
|---|---|
| Receipt number | 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 13:04:54 |
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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
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
morikawa-h@med.osaka-cu.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003302
