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).
Trial ID: NCT04579874
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2021-01-07
Completion date: 2022-04-15
Sponsor: Fibronostics USA, Inc
Conditions: Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis; Liver Fibroses; Liver Inflammation; Liver Steatoses
Interventions: LIVERFASt
Locations: Henry Ford Health System; St. Louis University; Northwell Health, Inc; GCGA Physicians, LLC; Methodist Health System Clinical Research Institute; Baylor College of Medicine; Houston Methodist Research Institute; Liver Associates of Texas, P.A.
Countries: United States; United States; United States; United States; United States; United States; United States; United States
Enrollment: 241
Age range: 18 Years - 80 Years
Sex: ALL

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

Eligibility criteria:
Inclusion Criteria:

* • Consenting patients with suspected NAFLD (by any means) having had undergone liver biopsy as part as their routine management, simultaneously or within six months from the day of blood sampling for LIVERFAStTM test.

  * Aged 18 to 80 years old, inclusive
  * Male or Female from any ethnicity
  * Willing to undergo blood sampling for LIVERFAStTM testing after 6 to 12 hours fasting
  * Willing to allow histological lecture by a pathologist for NASH-CRN and SAF scoring systems analysis of the liver biopsy
  * Willing and able to allow access to requested data and who were informed and signed the consent form.

Exclusion Criteria:

* • Inability to provide informed consent

  * Patients who may be uncooperative with the sample collection procedures
  * History of known Severe coagulopathy
  * History of known Hepatic abscess
  * Renal failure undergoing dialysis (GFR\<45)
  * History of Malignancy in the past 2 years
  * Previous liver transplantation
  * Suffering with a terminal illness or any other conditions or diseases that the investigator considers inappropriate for study participation
  * Secondary causes of hepatic fat accumulation such as significant alcohol consumption, long-term use of a steatogenic medication, ()
  * Ongoing or recent significant alcohol consumption defined as \>21 standard drinks on average per week in men and \>14 standard drinks on average per week in women.8 Approximately 10 g of alcohol equals one 'drink' unit. One unit equals 1 ounce of distilled spirits, one 12-oz beer, or one 4-oz glass of wine.
  * Total parenteral nutrition within 3 months of interview
  * Short bowel syndrome
  * History of gastric or jejunoileal bypass preceding the diagnosis of NAFLD. Bariatric surgery performed concomitant with or following the diagnosis of NAFLD does not exclude enrollment of patients.
  * History of biliopancreatic diversion
  * Evidence of advanced liver disease defined as a Child-Pugh-Turcotte score of equal to or greater than 10
  * Evidence of chronic hepatitis B as marked by the presence of HBsAg in serum (patients with isolated antibody to hepatitis B core antigen, anti-HBc, are not excluded)
  * Evidence of chronic hepatitis C as marked by the presence of anti-HCV and HCV RNA in serum; patients with anti-HCV with PCR negative should not be excluded
  * Low alpha-1-antitrypsin level and ZZ phenotype (both determined at the discretion of the investigator)
  * History of Wilson's disease
  * Known glycogen storage disease
  * Known dysbetalipoproteinemia
  * Known phenotypic hemochromatosis (determined at the discretion of the investigator)
  * History of primary biliary cholangitis (PBC)/primary biliary sclerosis (PSC)
  * Hepatic vascular lesions (determined at the discretion of the investigator)
  * History of liver liver granulomas sarcoidosis, and infectious diseases such as tuberculosis)
  * Congenital hepatic fibrosis, polycystic liver disease
  * Other metabolic/congenital liver disease
  * Evidence of systemic infectious disease
  * Known HIV positive
  * Disseminated or advanced extrahepatic malignancy
  * Conditions that could interfere with LIVERFASt parameters and could lead to risk of false positive/ false negative results:

    1. Drug induced liver-injury (DILI), acute alcoholic hepatitis
    2. Acute inflammatory syndrome or sepsis Active drug use or dependence that, in the opinion of the study investigator, would interfere with adherence to study requirements

Outcomes:
Clinical performance of LIVERFASt Tests to determine liver fibrosis scores and staging compared with Liver Biopsy in patients with presumed Non-Alcoholic Fatty Liver Disease (NAFLD).; Clinical performance of LIVERFASt Tests to determine inflammatory activity scores and staging compared with Liver Biopsy in patients with presumed Non-Alcoholic Fatty Liver Disease (NAFLD).; Clinical performance of LIVERFAStTM Tests to determine steatosis grading compared with Liver Biopsy in patients with presumed Non-Alcoholic Fatty Liver Disease (NAFLD).