Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease

Chronic Hepatitis B Clinical Trial

— FIBROELAST  

Official title:

Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01360879
• Other study ID #: JLOG1002
• Status: Recruiting
• Phase: N/A
• First received: May 21, 2011
• Last updated: May 25, 2011
• Start date: September 2010
• Est. completion date: September 2013

Study information

• Verified date: August 2010
• Source: Japan Liver Oncology Group
• Contact: Norihisa Yada, M.D.
• Phone: +81-72-366-0221
• Email: yada[@]med.kindai.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Diseases

Locations

Country	Name	City	State
Japan	Kinki University Faculty of Medicine	Osaka-sayama	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Japan Liver Oncology Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one year	No
Secondary	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.	one year	No
Secondary	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.	one year	No