N/A
N=907
FibroScan in Patients With Hepatitis B and C Presenting for Liver Biopsy
Cirrhosis · Hepatitis B · Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT00125762 ↗Enrolled (actual)
907
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Diagnosis Performance of VCTE for Determination of Cirrhosis (Metavir F4) in Patients With Chronic Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) — 0.92 ROC area
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FibroScan (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Afdhal, Nezam, M.D.
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnosis Performance of VCTE for Determination of Cirrhosis (Metavir F4) in Patients With Chronic Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) |
0.92 | — |
| PRIMARY Diagnostic Accuracy of VCTE for the Prediction of Metavir Fibrosis Scores by Differentiating no/Mild (F0/F1) From Severe Fibrosis (F2 - F4) |
0.89 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00125762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.