- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00125762
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
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- BIDMC
-
-
Missouri
-
Saint Louis, Missouri, United States
- Bruce Bacon M.D.
-
-
North Carolina
-
Durham, North Carolina, United States
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm undergoing FibroScan
Single arm active comparison of biopsy to vibration controlled elastography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
28 days
|
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
|
Liver Biopsy and VCTE within a time frame of 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nezam H Afdhal, M.D., Beth Israel Deaconess Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis C
Other Study ID Numbers
- 2004P000251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis B
-
Ain Shams UniversityCompleted
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...Gilead SciencesNot yet recruiting
-
National Taiwan University HospitalChiayi Christian Hospital; E-DA Hospital; Taipei City Hospital; Taipei Tzu Chi... and other collaboratorsRecruitingChronic Hepatitis b | Hepatitis B ReactivationTaiwan
-
Mahidol UniversityUnknownChronic Hepatitis B, HBsAg, Hepatitis B VaccineThailand
-
Nanfang Hospital of Southern Medical UniversityRecruiting
-
IlDong Pharmaceutical Co LtdRecruitingChronic Hepatitis bKorea, Republic of
-
Antios Therapeutics, IncTerminatedChronic Hepatitis bUnited States
-
Xi'an Xintong Pharmaceutical Research Co.,Ltd.Unknown
-
Tongji HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.UnknownChronic Hepatitis b
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruitingChronic Hepatitis b | Cirrhosis Due to Hepatitis BChina
Clinical Trials on FibroScan
-
EchosensRecruitingSpleen; FibrosisSpain, Netherlands, Romania
-
Assiut UniversityNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisTerminatedHepatitis, Viral, HumanFrance
-
Helen Kovari-KramerSwiss HIV Cohort StudyUnknownHIV Infection and Chronic Alanine Aminotransferase ElevationSwitzerland
-
Centre Hospitalier Universitaire DijonCompletedHepatic Steatosis | Pituitary Gland FailureFrance
-
HaEmek Medical Center, IsraelTerminatedPatients With Fatty Liver DiseaseIsrael
-
Icahn School of Medicine at Mount SinaiNational Institutes of Health (NIH)CompletedNASH - Nonalcoholic Steatohepatitis | Steatosis of LiverUnited States
-
University of AarhusActive, not recruitingLiver Inflammation | Primary Biliary CirrhosisDenmark
-
King's College Hospital NHS TrustUnknownLiver Diseases | Pregnancy Disease
-
Chang Gung Memorial HospitalUnknown