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

NCT04579874 | Completed FDA Device

• 1 other identifier: Fibro-US-001-0200
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 8

Brief 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

Conditions

Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis; Liver Fibroses; Liver Inflammation; Liver Steatoses

Keywords

LIVERFASt; Liver biopsy; Liver Fibrosis; Liver Activity; Liver Steatosis; Non-invasive serum biomarker; Neural Network; Artificial Intelligence Machine Learning; Algorithm based test

Outcome Measures

Primary Outcomes (3)

• 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).

  Primary: Clinical performance of the LIVERFASt Fibrosis score using the results of five serum biomarkers (A2M, Haptoglobin, ApoA1, Total Bilrubin and GGT) for the over-all diagnostic of liver fibrosis (F0, F1, F2, F3 and F4 stages) using Binary and Non-Binary-Area Under the ROC curve

  12 months

• 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 the LIVERFASt Activity scores using the results of six serum biomarkers (A2M, Haptoglobin, ApoA1, Total Bilrubin, GGT and ALT) for the over-all diagnostic of inflammatory activity (A0, A1, A2, A3 and A4 grades) using Binary and Non-Binary-Area Under the ROC curve

  12 months

• Clinical performance of LIVERFAStTM Tests to determine steatosis grading compared with Liver Biopsy in patients with presumed Non-Alcoholic Fatty Liver Disease (NAFLD).

  Clinical performance of the LIVERFAstTM Steatosis grading tests using the results of ten serum biomarkers (A2M, Haptoglobin, ApoA1, Total Bilrubin, GGT, ALT, AST, Triglyceride, Cholesterol and Fasting Blood Glucose) for the over-all diagnostic of steatosis (S0, S1, S2 and S3), using Binary and Non-Binary-Area Under the ROC curve

  12 months

Secondary Outcomes (1)

• Clinical performance evaluation of the LIVERFASt Tests to evaluate and measure the definition of NAFLD based on fibrosis staging (F0, F1, F2, F3 and F4), inflammatory activity (A0, A1, A2, A3 and A4) and steatosis grading (S0, S1, S2, and S3).

  12 months

Study Arms (1)

LIVERFASt validation

EXPERIMENTAL

blood draw for LIVERFASt

Diagnostic Test: LIVERFASt

Interventions

LIVERFASt DIAGNOSTIC_TEST

blood draw

LIVERFASt validation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fibronostics USA, Inc: lead

Study Sites (8)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

St. Louis University

St Louis, Missouri, 63103, United States

Location

Northwell Health, Inc

Manhasset, New York, 11030, United States

Location

GCGA Physicians, LLC

Cincinnati, Ohio, 45249, United States

Location

Methodist Health System Clinical Research Institute

Dallas, Texas, 75203, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Liver Associates of Texas, P.A.

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Hepatitis; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald Quiambao, MD

  Fibronostics USA, Inc

  STUDY DIRECTOR

• Imtiaz Alam, MD

  Ohio Gastroenterology and Liver Institute

  PRINCIPAL INVESTIGATOR

• Sven Henrichwark

  Fibronostics USA, Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 8, 2020
• Study Start: January 7, 2021
• Primary Completion: December 15, 2021
• Study Completion: April 15, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

US (8)