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
1 other identifier
interventional
907
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2005
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 1, 2005
CompletedFirst Posted
Study publicly available on registry
August 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
October 27, 2017
CompletedOctober 27, 2017
September 1, 2017
3.2 years
August 1, 2005
March 22, 2017
September 28, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Diagnosis Performance of VCTE for Determination of Cirrhosis (Metavir F4) in Patients With Chronic Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
VCTE was used to diagnose cirrhosis F4 in 748 patients undergoing liver biopsy and VCTE within a 28 day time period.
28 days
Diagnostic Accuracy of VCTE for the Prediction of Metavir Fibrosis Scores by Differentiating no/Mild (F0/F1) From Severe Fibrosis (F2 - F4)
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
Liver Biopsy and VCTE within a time frame of 6 months
Study Arms (1)
Single Arm undergoing FibroScan
EXPERIMENTALSingle arm active comparison of biopsy to vibration controlled elastography
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Afdhal, Nezam, M.D.lead
- Echosenscollaborator
Study Sites (3)
BIDMC
Boston, Massachusetts, 02215, United States
Bruce Bacon M.D.
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Related Publications (1)
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.
PMID: 25528010RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nezam Afdhal
- Organization
- BIDMC
Study Officials
- PRINCIPAL INVESTIGATOR
Nezam H Afdhal, M.D.
Beth Israel Deaconess Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Investigator unaware of biopsy results
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Part-time
Study Record Dates
First Submitted
August 1, 2005
First Posted
August 2, 2005
Study Start
March 1, 2005
Primary Completion
May 1, 2008
Study Completion
October 1, 2008
Last Updated
October 27, 2017
Results First Posted
October 27, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share