Validation of the LiverFASt Test and the Associated Fibrosis Staging Scores Compared to Liver Tissue Pathology Via Liver Biopsy

Withdrawn before enrolling

Conditions studied: NAFLD, NASH

In brief

This study is to assess the diagnostic performance of the LiverFASt Test for assessing fibrosis staging scores compared to the assessment of liver tissue pathology from liver biopsy.

Key facts

Study ID

NCT03980912

Run by

Fibronostics USA, Inc

People needed

0

Starts

2019-09-01

Expected to finish

2020-11-01

Last updated by the study team

2021-02-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 to 80 years old, inclusive
• Male or Female
• Liver patients who are scheduled to undergo, or have recently undergone, a medically indicated liver biopsy. Patients with a prior biopsy may be included under the following conditions:
• The biopsy was performed within the 3 months prior to enrollment
• A full report is available, including degree of Fibrosis, Activity and Steatosis or residual liver tissue is available for additional review.
• Have a full component of biomarkers available for analysis from a blood sample obtained within 3 months of the date of the biopsy. Participants without a full component of biomarkers may be included if an additional sample for analysis of the missing biomarkers can be obtained within 3 months of the date of the biopsy.
• Required biomarkers include: α2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, y-glutamyl transpeptidase (GGT), alanine aminotransferase (ALT), aspartate transaminase (AST), triglycerides, cholesterol, and fasting glucose, collected within 3 months
• Willing and able to allow access to requested data and who were informed and signed the consent form

You may not qualify if…

• Known psychiatric conditions
• Patients who may be uncooperative with the sample collection procedures
• Severe coagulopathy or infection of the hepatic bed
• Extrahepatic biliary obstruction
• Severe cardiovascular disease and/or renal failure
• Malignancy, except for resolved basal-cell carcinoma
• Previous liver transplant
• Suffering with a terminal illness or any other conditions or diseases that the investigator considers inappropriate for study participation

Where it is running

• ObvioHealth — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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