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Completed Not applicable Interventional

Clinical Performance of LIVERFASt Test Compared w/ Liver Biopsy in Patients w/ NAFLD.

ClinicalTrials.gov ID: NCT04579874

Public ClinicalTrials.gov record NCT04579874. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 18, 2026, 8:21 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Clinical Performance Evaluation of LIVERFASt Tests to Determine Fibrosis Staging, Inflammatory Activity and Steatosis Grading Compared w/ Liver Biopsy in Patients w/ Metabolic Factors & Presumed Non-Alcoholic Fatty Liver Disease (NAFLD).

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective of this study is to assess the clinical performance of LIVERFAStTM In Vitro Diagnostic (IVD) Tests (Fibrosis score, Activity score and Steatosis score) in NAFLD suspected patients for staging of fibrosis and for grading of inflammatory activity and steatosis, taking as reference the liver biopsy with histological classification of the elementary lesions determined according to SAF scores (Bedossa P., Hepatology 2012). The secondary objective is to assess the performance of LIVERFAStTM for the histological definition of NAFLD, including NAFL and NASH and severe NASH

Study identification

NCT ID
NCT04579874
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Fibronostics USA, Inc
Other
Enrollment
241 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 7, 2021 (Actual)
Primary completion
Dec 15, 2021 (Actual)
Completion
Apr 15, 2022 (Actual)
Last update posted
Aug 2, 2022

2021 – 2022

United States locations

U.S. sites
8
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
Henry Ford Health System Detroit Michigan 48202 —
St. Louis University St Louis Missouri 63103 —
Northwell Health, Inc Manhasset New York 11030 —
GCGA Physicians, LLC Cincinnati Ohio 45249 —
Methodist Health System Clinical Research Institute Dallas Texas 75203 —
Baylor College of Medicine Houston Texas 77030 —
Houston Methodist Research Institute Houston Texas 77030 —
Liver Associates of Texas, P.A. Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04579874, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 2, 2022 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04579874 live on ClinicalTrials.gov.

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