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

Further Study Details: 

Primary Outcomes: 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)
Expected Total Enrollment:  300

STUDY OBJECTIVES

Co –Primary Aims: 1. To diagnose cirrhosis in patients with chronic viral hepatitis B and C

2. To determine the 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. Site Investigators Duke University Medical Center Keyur Patel, MD Durham, NC Beth Israel Deaconess Medical Center Nezam H. Afdhal, M.D. Harvard Medical School Boston, MA St. Louis University Bruce R. Bacon M.D. St. Louis, MO

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 300 evaluable patients (males and females) will be enrolled in this study. Enrollment will be considered competitive allowing any one center to enroll up to 150 patients meeting study criteria to meet the goal of 300 subjects. Sample size is based on a prevalence of 20% cirrhosis.

Subject Inclusion Criteria:

1. Subject is able to give informed consent for this study and agrees to provide a blood sample. 2. Subject must be at least 18 years of age. 3. 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). 4. 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:

1. Unable or unwilling to provide informed consent. 2. Confirmed diagnosis and/or history of malignancy, or other terminal disease. 3. Uninterpretable biopsy specimen. 4. Missing critical clinical, biochemical and/or demographic information. 5. Receiving anti-viral therapy for infection of HCV or HBV within 3 months prior to the FibroScan and liver biopsy. 6. Subject with other chronic liver disease, including Wilson’s disease, 1-antitrypsin deficiency, cholestatic liver disease, or hemochromatosis. 7. Patient with clinical ascites 8. Patients with morbid obesity defined as a BMI of greater than or equal to 40. 9. Patients who are pregnant 10. 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 1. Subject is able to give informed consent for this study and agrees to provide a blood sample. 2. Subject must be at least 18 years of age. 3. 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). 4. 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:

• 1. Unable or unwilling to provide informed consent. 2. Confirmed diagnosis and/or history of malignancy, or other terminal disease. 3. Uninterpretable biopsy specimen. 4. Missing critical clinical, biochemical and/or demographic information. 5. Receiving anti-viral therapy for infection of HCV or HBV within 3 months prior to the FibroScan and liver biopsy. 6. Subject with other chronic liver disease, including Wilson’s disease, 1-antitrypsin deficiency, cholestatic liver disease, or hemochromatosis. 7. Patient with clinical ascites 8. Patients with morbid obesity defined as a BMI of greater than or equal to 40. 9. Patients who are pregnant 10. Patients who have an implantable cardiac device such as defibrillator or pacemaker

Please refer to this study by ClinicalTrials.gov identifier  NCT00125762

Nezam H Afdhal, M.D.      1 617 632 1118    nafdhal@bidmc.harvard.edu

Massachusetts
      BIDMC, Boston,  Massachusetts,  02215,  United States; Recruiting
Missouri
      Bruce Bacon M.D., St. Louis,  Missouri,  United States; Recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  United States; Recruiting

Study chairs or principal investigators

Nezam H Afdhal, M.D.,  Principal Investigator,  Beth Israel Deaconess Medical Center   

Study ID Numbers:  2004p-000251
Last Updated:  August 1, 2005
Record first received:  August 1, 2005
ClinicalTrials.gov Identifier:  NCT00125762
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02