NCT01360879

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Kindai University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2011-05-26
• Last updated: 2011-05-26

Locations

1 site across 1 country: Japan