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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00125762
First Posted: August 2, 2005
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Echosens
Information provided by (Responsible Party):
Nezam H. Afdhal, Beth Israel Deaconess Medical Center
August 1, 2005
August 2, 2005
March 22, 2017
October 27, 2017
October 27, 2017
March 2005
May 1, 2008   (Final data collection date for primary outcome measure)
  • 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.
  • 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
  • To diagnose cirrhosis in patients with chronic HBV and HCV
  • To detremine correlation of FibroScan measurement with Metavir Fibrosis scores by differentiating no/mild (F0/F1) from severe fibrosis (F2 - F4)
Complete list of historical versions of study NCT00125762 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
FibroScan in Patients With Hepatitis B and C Presenting for Liver Biopsy
Comparison of FibroScan With Histological Evaluations of Liver Fibrosis in Patients With Hepatitis B and C Presenting for Liver Biopsy
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.

STUDY OBJECTIVES:

Co -Primary Aims:

  • Diagnosis of cirrhosis in patients with chronic viral hepatitis B and C;
  • Correlation of the FibroScan measurement with Metavir liver fibrosis scores by differentiating no/mild fibrosis (F0-F1) from severe fibrosis (F2-F4).

STUDY DESIGN:

This is a multi-center study in which the FibroScan measurements will be collected prospectively from patients with chronic hepatitis B and C virus presenting for liver biopsy. The study duration will be 12 months. The study will initially have 3 investigational sites in the United States. Up to 3 more investigational sites may be identified to participate in the trial.

Study Sites:

Initially the following three sites will participate in the trial:

Duke University Medical Center, Durham, NC: Keyur Patel, M.D.; Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA: Nezam H. Afdhal, M.D.; St. Louis University, St. Louis, MO: Bruce R. Bacon M.D.

Study Population:

Subjects with chronic liver diseases secondary to chronic hepatitis C and hepatitis B, undergoing a liver biopsy as the standard of care for their disease, will be eligible for the study. Subjects with hepatitis C, co-infected with other infectious viral diseases, such as hepatitis B or HIV-1, or both, may also be candidates for study enrollment provided the inclusion/exclusion criteria are met.

The subjects must be scheduled for liver biopsy either prior to treatment (treatment naïve) or, if previously treated, they must have been off treatment for at least three (3) months. The time between the date of the FibroScan reading and the date of biopsy must not exceed six (6) months.

Sample Size:

A total of at least 300 evaluable patients (males and females) will be enrolled in this study. Enrollment will be considered competitive with no site enrolling more than 50% of the study population. Sample size is based on a prevalence of 20% cirrhosis.

Subject 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.

Subject 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 body mass index (BMI) of greater than or equal to 40.
  • Patients who are pregnant
  • Patients who have an implantable cardiac device such as defibrillator or pacemaker

SAMPLE REQUIREMENTS and TESTING:

A minimum of 8 valid measurements will be obtained for each subject from the right lobe of the liver. The tip of the probe transducer will be covered with coupling gel and placed on the skin, between the ribs at the level of the right lobe of the liver. The operator, assisted by an ultrasonic time motion image, will locate a portion of the liver that is at least 4cm thick and free of large vascular structures. The depth of measurement will be between 25 mm and 65 mm. During the acquisition subjects will lie on their back with the right arm behind the head, in a similar position to that used for liver biopsy. The physician will take the measurements with the probe placed in the intercostal space. The median value of the estimates will be kept as the elasticity value of the liver for a given patient. The entire examination should last approximately 5 minutes.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Investigator unaware of biopsy results
Primary Purpose: Diagnostic
  • Cirrhosis
  • Hepatitis B
  • Hepatitis C
Device: FibroScan
Experimental: Single Arm undergoing FibroScan
Single arm active comparison of biopsy to vibration controlled elastography
Intervention: Device: FibroScan
Afdhal NH, Bacon BR, Patel K, Lawitz EJ, Gordon SC, Nelson DR, Challies TL, Nasser I, Garg J, Wei LJ, McHutchison JG. Accuracy of fibroscan, compared with histology, in analysis of liver fibrosis in patients with hepatitis B or C: a United States multicenter study. Clin Gastroenterol Hepatol. 2015 Apr;13(4):772-9.e1-3. doi: 10.1016/j.cgh.2014.12.014. Epub 2014 Dec 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
907
October 1, 2008
May 1, 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00125762
2004P000251
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Plan to Share IPD: No
Nezam H. Afdhal, Beth Israel Deaconess Medical Center
Afdhal, Nezam, M.D.
Echosens
Principal Investigator: Nezam H Afdhal, M.D. Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP