Status:
COMPLETED
FibroScan in Patients With Hepatitis B and C Presenting for Liver Biopsy
Lead Sponsor:
Afdhal, Nezam, M.D.
Collaborating Sponsors:
Echosens
Conditions:
Cirrhosis
Hepatitis B
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 l...
Detailed Description
STUDY OBJECTIVES: Co -Primary Aims: * Diagnosis of cirrhosis in patients with chronic viral hepatitis B and C; * Correlation of the FibroScan measurement with Metavir liver fibrosis scores by differ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
907 Patients enrolled
Trial Details
Trial ID
NCT00125762
Start Date
March 1 2005
End Date
October 1 2008
Last Update
October 27 2017
Active Locations (3)
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1
BIDMC
Boston, Massachusetts, United States, 02215
2
Bruce Bacon M.D.
St Louis, Missouri, United States
3
Duke University Medical Center
Durham, North Carolina, United States