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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Echosens
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00125762
First received: August 1, 2005
Last updated: August 12, 2005
Last verified: July 2005
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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

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

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

ClinicalTrials.gov processed this record on May 22, 2013