FibroScan in Patients With Hepatitis B and C Presenting for Liver Biopsy

Completed · Not applicable

Conditions studied: Cirrhosis, Hepatitis B, Hepatitis C

In brief

This study will examine the effectiveness of the FibroScan device in differentiating fibrosis in patients with hepatitis B and C. The FibroScan measures liver stiffness and will be correlated to the liver biopsy to see if it can diagnose the stage of liver disease. Patients who are scheduled to have a liver biopsy will also have a fibroscan and the stiffness will be correlated with the biopsy stage.

Key facts

Study ID

NCT00125762

Run by

Afdhal, Nezam, M.D.

People needed

907

Starts

2005-03-01

Expected to finish

2008-10-01

Last updated by the study team

2017-10-27

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is able to give informed consent for this study and agrees to provide a blood sample.
• Subject must be at least 18 years of age.
• Subject has had or will have a liver biopsy for chronic liver disease, secondary to HBV or HCV or within 6 months of FibroScan (experimental cohort 1 only).
• Subjects who have hepatitis C (HCV) or hepatitis B (HBV) should be treatment naïve or off interferon therapy or nucleoside/nucleotide analogs for HBV for a minimum of 3 months prior to the FibroScan and liver biopsy.

You may not qualify if…

• Unable or unwilling to provide informed consent.
• Confirmed diagnosis and/or history of malignancy, or other terminal disease.
• Uninterpretable biopsy specimen.
• Missing critical clinical, biochemical and/or demographic information.
• Receiving anti-viral therapy for infection of HCV or HBV within 3 months prior to the FibroScan and liver biopsy.
• Subject with other chronic liver disease, including Wilson's disease, alpha 1-antitrypsin deficiency, cholestatic liver disease, or hemochromatosis.
• Patient with clinical ascites.
• Patients with morbid obesity defined as a BMI of greater than or equal to 40.
• Patients who are pregnant.
• Patients who have an implantable cardiac device such as defibrillator or pacemaker.

Where it is running

• BIDMC — Boston, Massachusetts, United States
• Bruce Bacon M.D. — St Louis, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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