Trial Outcomes & Findings for FibroScan in Patients With Hepatitis B and C Presenting for Liver Biopsy (NCT NCT00125762)

NCT ID: NCT00125762

Last Updated: 2017-10-27

Results Overview

VCTE was used to diagnose cirrhosis F4 in 748 patients undergoing liver biopsy and VCTE within a 28 day time period.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 907 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2017-10-27

Participant Flow

Participant milestones

Measure	Active Arm All patients received a liver biopsy and a FibroScan
Overall Study STARTED	907
Overall Study COMPLETED	748
Overall Study NOT COMPLETED	159

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The analysis is for patients who completed both the liver biopsy and the FibroScan

Baseline characteristics by cohort

Measure	Single Arm Undergoing FibroScan n=907 Participants Single arm active comparison of biopsy to vibration controlled elastography FibroScan
Age, Categorical <=18 years	0 Participants n=907 Participants
Age, Categorical Between 18 and 65 years	907 Participants n=907 Participants
Age, Categorical >=65 years	0 Participants n=907 Participants
Age, Continuous	49.9 years STANDARD_DEVIATION 8.8 • n=907 Participants
Sex: Female, Male Female	257 Participants n=748 Participants • The analysis is for patients who completed both the liver biopsy and the FibroScan
Sex: Female, Male Male	491 Participants n=748 Participants • The analysis is for patients who completed both the liver biopsy and the FibroScan
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=907 Participants
Race (NIH/OMB) Asian	0 Participants n=907 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=907 Participants
Race (NIH/OMB) Black or African American	0 Participants n=907 Participants
Race (NIH/OMB) White	586 Participants n=907 Participants
Race (NIH/OMB) More than one race	0 Participants n=907 Participants
Race (NIH/OMB) Unknown or Not Reported	321 Participants n=907 Participants
Region of Enrollment United States	907 participants n=907 Participants

PRIMARY outcome

Timeframe: 28 days

Population: 748 patients were eligible for analysis with matching valid liver biopsies and VCTE measurements.

VCTE was used to diagnose cirrhosis F4 in 748 patients undergoing liver biopsy and VCTE within a 28 day time period.

Outcome measures

Measure	Single Arm Undergoing FibroScan n=748 Participants Single arm active comparison of biopsy to vibration controlled elastography FibroScan
Diagnosis Performance of VCTE for Determination of Cirrhosis (Metavir F4) in Patients With Chronic Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)	0.92 ROC area Interval 0.87 to 0.95

PRIMARY outcome

Timeframe: Liver Biopsy and VCTE within a time frame of 6 months

Population: 456 patients with matching liver biopsy and fibroscan

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

Outcome measures

Measure	Single Arm Undergoing FibroScan n=456 Participants Single arm active comparison of biopsy to vibration controlled elastography FibroScan
Diagnostic Accuracy of VCTE for the Prediction of Metavir Fibrosis Scores by Differentiating no/Mild (F0/F1) From Severe Fibrosis (F2 - F4)	0.89 ROC area Interval 0.83 to 0.92

Adverse Events

Active Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nezam Afdhal

BIDMC

Phone: 6176321118

Email: nafdhal@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place