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
Information provided by:
Beth Israel Deaconess Medical Center
First received: August 1, 2005
Last updated: August 12, 2005
Last verified: July 2005
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.
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||Comparison of FibroScan With Histological Evaluations of Liver Fibrosis in Patients With Hepatitis B and C Presenting for Liver Biopsy
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:
| Study Start Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125762
|Boston, Massachusetts, United States, 02215 |
|Contact: Rory Farnan 617-632-1070 firstname.lastname@example.org |
|Principal Investigator: Nezam H Afdhal, M.D. |
|Bruce Bacon M.D.
|St. Louis, Missouri, United States |
|Contact: Judy Thompson 314-577-8764 |
|Principal Investigator: Bruce Bacon, M.D. |
|Duke University Medical Center
|Durham, North Carolina, United States |
|Contact: Keyur Patel, M.D. |
|Principal Investigator: Keyur Patel, M.D. |
Afdhal, Nezam, M.D.
||Nezam H Afdhal, M.D.
||Beth Israel Deaconess Medical Center
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 1, 2005
||August 12, 2005
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections