CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 907 enrolled
Drug / intervention
FibroScandevice
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Chronic liver disease secondary to HBV or HCV with planned or prior liver biopsy
  • ✓Liver biopsy performed within 6 months of FibroScan
  • ✓Treatment-naïve OR ≥3 months off antiviral therapy before FibroScan and biopsy
  • ✓Age ≥18 years
Key exclusion· 8
  • ✕Active malignancy or terminal disease
  • ✕Receiving antiviral therapy for HCV or HBV within 3 months before FibroScan and biopsy
  • ✕Other chronic liver disease (Wilson's disease, alpha-1 antitrypsin deficiency, cholestasis, hemochromatosis)
  • ✕Clinical ascites

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00125762
NCT00125762N/ACompleted
CompareCT.gov

Comparison of FibroScan With Histological Evaluations of Liver Fibrosis in Patients With Hepatitis B and C Presenting for Liver Biopsy

Afdhal, Nezam, M.D.·interventional·Posted Aug 2, 2005·Updated Oct 27, 2017

In Brief

A clinical study evaluating FibroScan for Cirrhosis and 2 related conditions. Completed, enrolled 907 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCirrhosis, Hepatitis B, Hepatitis C
CountriesUnited States
CollaboratorsEchosens

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2, 2005
Enrollment StartMar 1, 2005
Primary CompletionMay 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 20.9 years ago

Interventions

FibroScandevice