Status:
COMPLETED
ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B
Lead Sponsor:
SuperSonic Imagine
Conditions:
Liver Fibrosis
Eligibility:
All Genders
18+ years
Brief 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 a...
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 treatm...
Eligibility Criteria
Inclusion
- Patients undergoing a liver ultrasound exam due to confirmed Hepatitis B infection ,
- Patients having reached the age of majority in China,
- Patients with a liver biopsy for histological evaluation of liver fibrosis, performed within 3 months after the SWE measurement date, and having the recommended quality criterion:
- minimal length of biopsy samples of 15 mm, stored in paraffin
- Minimal number of portal tracts of 6 per biopsy samples
- Patients of Chinese ethnic origin
Exclusion
- Any patient presenting with combined etiologies of chronic liver diseases, including non-Hepatitis B viral infection（Hepatitis A, C, D, E, chronic alcoholic liver disease, hemochromatosis, autoimmune hepatitis, etc)
- History of antiviral therapy at any time
- Any patient presenting with a co-infection of HIV
- Any patient presenting with combined liver malignant tumor
- Previous liver transplantation
- Pregnant women
- Any patient with combined hepatic congestive condition such as Budd Chiari Syndrome, congestive heart failure, chronic constrictive pericarditis…
- Any patient combined with intrahepatic cholestasis
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT02313649
Start Date
December 1 2014
End Date
April 1 2016
Last Update
April 19 2016
Active Locations (15)
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1
People's Liberation Army General（301）Hospital
Beijing, China
2
West China Hospital, Sichuan University
Chengdu, China
3
1st Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China
4
3rd Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China