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

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ClinicalTrials.gov Identifier: NCT00125762
Recruitment Status : Completed
First Posted : August 2, 2005
Results First Posted : October 27, 2017
Last Update Posted : October 27, 2017
Information provided by (Responsible Party):
Nezam H. Afdhal, Beth Israel Deaconess Medical Center

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 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.

Condition or disease Intervention/treatment
Cirrhosis Hepatitis B Hepatitis C Device: FibroScan

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 907 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Investigator unaware of biopsy results
Primary Purpose: Diagnostic
Official Title: Comparison of FibroScan With Histological Evaluations of Liver Fibrosis in Patients With Hepatitis B and C Presenting for Liver Biopsy
Actual Study Start Date : March 2005
Primary Completion Date : May 1, 2008
Study Completion Date : October 1, 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single Arm undergoing FibroScan
Single arm active comparison of biopsy to vibration controlled elastography
Device: FibroScan

Primary Outcome Measures :
  1. Diagnosis Performance of VCTE for Determination of Cirrhosis (Metavir F4) in Patients With Chronic Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) [ Time Frame: 28 days ]
    VCTE was used to diagnose cirrhosis F4 in 748 patients undergoing liver biopsy and VCTE within a 28 day time period.

  2. Diagnostic Accuracy of VCTE for the Prediction of Metavir Fibrosis Scores by Differentiating no/Mild (F0/F1) From Severe Fibrosis (F2 - F4) [ Time Frame: Liver Biopsy and VCTE within a time frame of 6 months ]
    95% CI for Metavir Fibrosis stage 0 -1 consistent with no or mild fibrosis compared to Metavir 2 - 4 which represents significant fibrosis or cirrhosis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125762

United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Missouri
Bruce Bacon M.D.
Saint Louis, Missouri, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
Sponsors and Collaborators
Afdhal, Nezam, M.D.
Principal Investigator: Nezam H Afdhal, M.D. Beth Israel Deaconess Medical Center

Responsible Party: Nezam H. Afdhal, Professor of Medicine, Part-time, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00125762     History of Changes
Other Study ID Numbers: 2004P000251
First Posted: August 2, 2005    Key Record Dates
Results First Posted: October 27, 2017
Last Update Posted: October 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections