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

Non-Alcoholic Fatty Liver Disease Clinical Trial

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).

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

Chronic liver diseases (CLDs), such as chronic viral hepatitis, nonalcoholic fatty liver diseases (NAFLD) and nonalcoholic steatohepatitis (NASH), are a leading cause of morbidity and mortality globally and usually develops over many years. The prevalence of NAFLD has increased in recent years (15% in 2005 to 25% in 2010) mainly due to the increase prevalence of obesity and diabetes. As, approximately 20% of NAFLD cases develop NASH, the associated increase in NASH during the same period is to be expected (33% in 2005 to 59.1% in 2010).

As a result, staging of liver fibrosis is essential in determining the prognosis and optimal treatment for patients with NASH. Furthermore, evaluation of fibrosis in NAFLD patients can help refine treatment options designed to prevent the progression to NASH.

One recent study demonstrates significant sampling variability of routine liver biopsy in patients with NAFLD (Ratziu V. et al. Gastroenterology 2008). The diagnosis of NASH would have been missed in 35% and the discordance for steatosis grading was encountered in 22% of patients.

Developing safe and easily accessible noninvasive modalities to accurately evaluate fibrosis stage of NAFLD and NASH is of utmost importance in clinical practice.

Fibronostics breaks through the burden to serve patients. By empowering their providers with IVD clinical tools within the clinic, the ability to ensure screening and clinical adherence is assured, and the ease for early detection profoundly shifts the $2B economic burden.

LIVERFASt is a non-invasive clinical and staging In-Vitro-Diagnostic (IVD) tool, which has been developed as an alternative to liver biopsy. LIVERFASt is a safe, and reproducible tool which provides surrogate grading and staging of the three elementary features of NASH: steatosis, inflammatory activity and fibrosis.

LIVERFAStTM combines age, gender, weight and height with common liver function tests (ALT, AST, GGT, total bilirubin), lipid profile (total cholesterol, triglycerides), fasting glucose and three specific proteins of the liver with hepatoprotective functions and predictive value in NAFLD -alpha2-macroglobulin (A2M), haptoglobin (HAP) and apolipoprotein A1 (APOA1).

The main aim of this study is to evaluate the clinical value of LIVERFAStTM as a non-invasive biopsy-proven surrogate assessment of non-alcoholic fatty liver disease.

This is a cohort cross-sectional prospective, multi-centre study of an algorithm-based assessment of liver fibrosis, inflammatory activity (steatohepatitis) and steatosis compared to the histological assessment provided by liver biopsy performed in patients with suspected non-alcoholic steatohepatitis (NASH). ;

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Hepatitis
• Inflammation
• Liver Cirrhosis
• Liver Diseases
• Liver Fibroses
• Liver Inflammation
• Liver Steatoses
• Non-Alcoholic Fatty Liver Disease
• Non-Alcoholic Steatohepatitis

• NCT number: NCT04579874
• Study type: Interventional
• Source: Fibronostics USA, Inc
• Status: Completed
• Phase: N/A
• Start date: January 7, 2021
• Completion date: April 15, 2022