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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2005 by Beth Israel Deaconess Medical Center.
Recruitment status was:  Recruiting
Information provided by:
Beth Israel Deaconess Medical Center Identifier:
First received: August 1, 2005
Last updated: August 12, 2005
Last verified: July 2005
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 Intervention Phase
Hepatitis B
Hepatitis C
Device: FibroScan
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • To diagnose cirrhosis in patients with chronic hepatitis B virus (HBV) and hepatitis C virus (HCV)
  • To determine correlation of FibroScan measurement with Metavir fibrosis scores by differentiating no/mild (F0/F1) from severe fibrosis (F2 - F4)

Estimated Enrollment: 300
Study Start Date: March 2005
  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00125762

United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Missouri
Bruce Bacon M.D.
St. 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
  More Information Identifier: NCT00125762     History of Changes
Other Study ID Numbers: 2004p-000251 
Study First Received: August 1, 2005
Last Updated: August 12, 2005

Additional relevant MeSH terms:
Hepatitis C
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
Hepadnaviridae Infections
DNA Virus Infections processed this record on February 20, 2017