NCT02313649

ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B

Evaluation of ShearWave™ Elastography Performances for the Non-Invasive Assessment of Liver Fibrosis in Chinese Patients With Chronic Hepatitis B Infection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 447 (actual)
• Sponsor: SuperSonic Imagine · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard). The population that will be evaluated are Chinese patients infected with the Hepatitis B virus.

Detailed description

Hepatitis B is becoming increasingly common. The liver becomes stiffer and this is called fibrosis. A non-invasive method to accurately stage fibrosis is necessary in order to begin the correct treatment. Currently, liver biopsy is used to do this, but there are many disadvantages with this technique. ShearWave Elastography (SWE), available on the ultrasound machine Aixplorer®, is a non-invasive method to evaluate liver fibrosis. This study will evaluate how liver stiffness measurements made with SWE correspond with a biopsy result (currently the gold standard). The sensitivity, specificity, positive predictive value and negative predictive value of liver stiffness measurements with Aixplorer to evaluate the different stages of fibrosis will be analyzed. Liver stiffness measurement made by the Aixplorer will also be compared to blood markers

Conditions

• Liver Fibrosis

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-12-10
• Last updated: 2016-04-19

Locations

15 sites across 1 country: China