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

This study is currently recruiting participants.

Verified by Beth Israel Deaconess Medical Center, July 2005

First Received: August 1, 2005 Last Updated: August 12, 2005 History of Changes

Sponsors and Collaborators:	Afdhal, Nezam, M.D. Echosens
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00125762

Purpose

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
Cirrhosis Hepatitis B Hepatitis C	Device: FibroScan	Phase III

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis B Hepatitis C

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Comparison of FibroScan With Histological Evaluations of Liver Fibrosis in Patients With Hepatitis B and C Presenting for Liver Biopsy

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125762

Contacts

Contact: Nezam H Afdhal, M.D.

1 617 632 1118

nafdhal@bidmc.harvard.edu

Locations

United States, Massachusetts
BIDMC	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Rory Farnan 617-632-1070 rfarnan@bidmc.harvard.edu
Principal Investigator: Nezam H Afdhal, M.D.
United States, Missouri
Bruce Bacon M.D.	Recruiting
St. Louis, Missouri, United States
Contact: Judy Thompson 314-577-8764
Principal Investigator: Bruce Bacon, M.D.
United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States
Contact: Keyur Patel, M.D.
Principal Investigator: Keyur Patel, M.D.

Sponsors and Collaborators

Afdhal, Nezam, M.D.

Echosens

Investigators

Principal Investigator:

Nezam H Afdhal, M.D.

Beth Israel Deaconess Medical Center

More Information

No publications provided

Study ID Numbers:	2004p-000251
Study First Received:	August 1, 2005
Last Updated:	August 12, 2005
ClinicalTrials.gov Identifier:	NCT00125762 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatic Fibrosis
Fibrosis

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Liver Cirrhosis
Hepatitis C

Additional relevant MeSH terms:

Liver Diseases
RNA Virus Infections
Flaviviridae Infections
Fibrosis
Hepatitis, Viral, Human
Hepadnaviridae Infections
Hepatitis

Virus Diseases
Digestive System Diseases
Pathologic Processes
Hepatitis B
DNA Virus Infections
Hepatitis C

ClinicalTrials.gov processed this record on May 06, 2009