Clinical Performance of LIVERFASt Test Compared w/ Liver Biopsy in Patients w/ NAFLD.
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.
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
- Enrollment
- 241 participants
Conditions and interventions
Conditions
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 6, 2021
- Primary completion
- Dec 14, 2021
- Completion
- Apr 14, 2022
- Last update posted
- Aug 1, 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 1, 2022 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04579874 live on ClinicalTrials.gov.