Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125762
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2005-08-01
Brief Title:
FibroScan in Patients With Hepatitis B and C Presenting for Liver Biopsy
Sponsor:
Afdhal Nezam MD
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Comparison of FibroScan With Histological Evaluations of Liver Fibrosis in Patients With Hepatitis B and C Presenting for Liver Biopsy
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 nomild 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 MD Beth Israel Deaconess Medical Center and Harvard Medical School Boston MA Nezam H Afdhal MD St Louis University St Louis MO Bruce R Bacon MD
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 inclusionexclusion 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 nucleosidenucleotide 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 andor history of malignancy or other terminal disease
Uninterpretable biopsy specimen
Missing critical clinical biochemical andor 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 Wilsons 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
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 nomild 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 MD Beth Israel Deaconess Medical Center and Harvard Medical School Boston MA Nezam H Afdhal MD St Louis University St Louis MO Bruce R Bacon MD
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 inclusionexclusion 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 nucleosidenucleotide 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 andor history of malignancy or other terminal disease
Uninterpretable biopsy specimen
Missing critical clinical biochemical andor 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 Wilsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None