Chronic Hepatitis BFIBROELASTNCT01360879
Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
An observational study of Chronic Hepatitis B and Chronic Hepatitis C, run by Kindai University at 1 site in Japan.
Trial summary
This is a multi-center cross-sectional study in which the Real-time Tissue Elastography® measurements will be collected prospectively from patients with chronic hepatitis B or C virus presenting for liver biopsy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Hepatitis B, Chronic Hepatitis C
- How many people
- 500 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2010to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with chronic hepatitis B or C, undergoing a liver biopsy as the standard of care for their disease, will be eligible for the study. Subjects with other infectious viral diseases or chronic liver disease are excluded for study enrollment.
Who may be able to join
- Male or female and at least 20 years of age
- Chronic hepatitis B or Chronic hepatitis C
- Subject is willing to fast for 8 hours prior to each study visit
Who cannot join
- History of alcohol abuse (alcohol intake > 20g/day)
- Evidence or history of chronic hepatitis not caused by HBV or HCV
- During 6 months before registration to this trial has completed, nucleic acid analogue preparations or interferon therapy was performed.
- Pregnant or lactating patients
- Contraindications of liver biopsy or liver resection
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kinki University Faculty of Medicine
Ōsaka-sayama, Osaka, 589-8511
Norihisa Yada, MD, +81-72-366-0221 ext. 3525, yada@med.kindai.ac.jp
Kazuomi Ueshima, MD, +81-72-366-0221 ext. 3525, kaz-ues@med.kindi.ac.jp
About this study
This is a multi-center cross-sectional study in which the Real-time Tissue Elastography® measurements will be collected prospectively from patients with chronic hepatitis B or C virus presenting for liver biopsy.
Read the detailed description
The aim of this study is to validate the diagnostic value of Real-time Tissue Elastography® by comparison with liver histology, serum marker or FibroScan® in chronic hepatitis B or C patients.Real-time Tissue Elastography®, biopsy and serum maker are performed.
If in the hospital they can perform FibroScan®, FobroScan® also be performed. The subjects must be scheduled for liver biopsy either prior to treatment (treatment naïve) or, if previously treated, they must have been off treatment for at least six months. The time between the Real-time Tissue Elastography® , biopsy, blood sampling and FiroScan® must not exceed four weeks.
- Conditions
- Chronic Hepatitis B, Chronic Hepatitis C
- Keywords
- Hepatitis B virus, Hepatitis C virus, Chronic hepatitis, Liver cirrhosis, Liver stiffness, Liver fibrosis
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis C, Chronic, Hepatitis B, Hepatitis C, Hepatitis, Chronic, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and histological diagnosis
To evaluate the correlation between Real-time Tissue Elastography® index and histological diagnosis (the gold standard for liver fibrosis), we calculate sensitivity and specificity, ROC curves.
Sensitivity, specificity and ROC curves obtained under below stiations:
- liver fibrosis index diagnose of histological diagnosis F4
- liver fibrosis index diagnose of histological diagnosis F3 or greater
- liver fibrosis index diagnose of histological diagnosis F2 or greater
Measured: one year
Secondary outcomes (2)
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and serum maker
To evaluate the correlation between Real-time Tissue Elastography® index and serum markers of hepatic fibrosis, we estimate Pearson correlation coefficient of each request.
Measured: one year
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and FibroScan®
To evaluate the correlation between Real-time Tissue Elastography® index and FibroScan® index, we estimate Pearson correlation coefficient of each request.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kindai University
- Sponsor type
- University, hospital or other
- Investigators
- Masatoshi Kudo, Professor, Study chair, Kinki University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360879
- Sponsor's protocol ID
- JLOG1002
- Acronym
- FIBROELAST
- Status last verified
- Aug 2010
- First submitted
- 21 May 2011
- Last updated
- 26 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT01360879
- Acronym / sponsor ID
- FIBROELAST / JLOG1002
- Conditions
- Chronic Hepatitis B, Chronic Hepatitis C
- Keywords
- Hepatitis B virus, Hepatitis C virus, Chronic hepatitis, Liver cirrhosis, Liver stiffness, Liver fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kindai UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 26 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center cross-sectional study in which the Real-time Tissue Elastography® measurements will be collected prospectively from patients with chronic hepatitis B or C virus presenting for liver biopsy.
Detailed description
The aim of this study is to validate the diagnostic value of Real-time Tissue Elastography® by comparison with liver histology, serum marker or FibroScan® in chronic hepatitis B or C patients.Real-time Tissue Elastography®, biopsy and serum maker are performed.
If in the hospital they can perform FibroScan®, FobroScan® also be performed. The subjects must be scheduled for liver biopsy either prior to treatment (treatment naïve) or, if previously treated, they must have been off treatment for at least six months. The time between the Real-time Tissue Elastography® , biopsy, blood sampling and FiroScan® must not exceed four weeks.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with chronic hepatitis B or C, undergoing a liver biopsy as the standard of care for their disease, will be eligible for the study. Subjects with other infectious viral diseases or chronic liver disease are excluded for study enrollment.
Key inclusion criteria (3 listed)
- Male or female and at least 20 years of age
- Chronic hepatitis B or Chronic hepatitis C
- Subject is willing to fast for 8 hours prior to each study visit
Key exclusion criteria (5 listed)
- History of alcohol abuse (alcohol intake > 20g/day)
- Evidence or history of chronic hepatitis not caused by HBV or HCV
- During 6 months before registration to this trial has completed, nucleic acid analogue preparations or interferon therapy was performed.
- Pregnant or lactating patients
- Contraindications of liver biopsy or liver resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and histological diagnosis
Time frame: one year
To evaluate the correlation between Real-time Tissue Elastography® index and histological diagnosis (the gold standard for liver fibrosis), we calculate sensitivity and specificity, ROC curves. Sensitivity, specificity and ROC curves obtained under below stiations: 1. liver fibrosis index diagnose of histological diagnosis F4 2. liver fibrosis index diagnose of histological diagnosis F3 or greater 3. liver fibrosis index diagnose of histological diagnosis F2 or greater
2 secondary outcomes
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and serum maker
Time frame: one year
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and FibroScan®
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masatoshi Kudo, Professor study chair
Kinki University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B and Chronic Hepatitis C, run by Kindai University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norihisa Yada, M.D. (+81-72-366-0221 ext. 3525, yada@med.kindai.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and histological diagnosis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2011.