Fibrosure fibrotest

Manufactured by Labcorp

FibroSure/FibroTest is a blood-based biomarker test that provides an assessment of liver fibrosis and steatosis. The test analyzes a panel of biomarkers to generate an algorithm-based score that correlates with the degree of liver fibrosis and steatosis.

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Lab products found in correlation

M30 apoptosense, by Diapharma (1 mentions)

3 protocols using fibrosure fibrotest

Noninvasive Markers of Liver Fibrosis

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Changes from baseline in noninvasive markers of fibrosis, including the Enhanced Liver Fibrosis test (Siemens, Tarrytown, NY) and FibroSure/FibroTest (LabCorp, Burlington, NC), were assessed, as well as changes in markers of liver injury and function, including serum ALT, aspartate aminotransferase (AST), bilirubin, gamma‐glutamyltransferase, and alkaline phosphatase. Changes from baseline in serum levels of cytokeratin‐18 M30 and M65 fractions were measured as indicators of hepatocellular apoptosis and necrosis, respectively, using the M30 Apoptosense and M65 EpiDeath enzyme‐linked immunosorbent assays (Diapharma, West Chester, OH).

Loomba R., Lawitz E., Mantry P.S., Jayakumar S., Caldwell S.H., Arnold H., Diehl A.M., Djedjos C.S., Han L., Myers R.P., Subramanian G.M., McHutchison J.G., Goodman Z.D., Afdhal N.H, & Charlton M.R. (2017). The ASK1 inhibitor selonsertib in patients with nonalcoholic steatohepatitis: A randomized, phase 2 trial. Hepatology (Baltimore, Md.), 67(2), 549-559.

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Nonalcoholic Fatty Liver Disease Inclusion Criteria

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Eligible patients 18 to 75 years of age with a clinical diagnosis of nonalcoholic fatty liver disease (NAFLD) on the basis of imaging or liver biopsy within two years of screening were considered. Inclusion criteria included hepatic steatosis by MRI-PDFF ≥8% and liver stiffness by MRE ≥2.5 kPa during screening. Alternatively, patients with a liver biopsy within 12 months of screening consistent with a diagnosis of NASH with F1-F3 fibrosis according to the NASH Clinical Research Network (CRN) classification were eligible.^{16 (link)} We excluded patients with histologic or imaging evidence of cirrhosis; prior history of decompensated liver disease; or a FibroSure/FibroTest (LabCorp, Burlington, NC) result of ≥0.75 (unless a biopsy within 12 months excluded cirrhosis). Patients with alanine aminotransferase (ALT) >5 × the upper limit of normal (ULN), total bilirubin >1 × ULN, international normalized ratio (INR) >1.2, body mass index (BMI) <18 kg/m², or platelet count less than 100,000/mL³ were also excluded.

Loomba R., Kayali Z., Noureddin M., Ruane P., Lawitz E.J., Bennett M., Wang L., Harting E., Tarrant J.M., McColgan B.J., Chung C., Ray A.S., Subramanian G.M., Myers R.P., Middleton M.S., Lai M., Charlton M, & Harrison S.A. (2018). GS-0976 Reduces Hepatic Steatosis and Fibrosis Markers in Patients with Nonalcoholic Fatty Liver Disease. Gastroenterology, 155(5), 1463-1473.e6.

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Phase II Study of PSC Patients

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The study population included noncirrhotic patients with PSC who completed the randomized component of the phase II study (ClinicalTrials.gov NCT02943460) without permanently discontinuing study drug or placebo. As previously described, 10 patients with classic, large-duct PSC based on cholangiogram (magnetic resonance cholangiopancreatography, endoscopic retrograde cholangiopancreatography, or percutaneous transhepatic cholangiogram) within the previous 12 months were eligible. Patients had a serum ALP >1.67 Â the upper limit of normal (ULN) without evidence of hepatic synthetic dysfunction. Patients with a history of inflammatory bowel disease were required to have a colonoscopy within 6 months of screening demonstrating no evidence of active disease and a partial Mayo score of <2 with a score on the Rectal Bleeding domain <1 during screening. Exclusion criteria included histologic or imaging evidence of cirrhosis; prior history of decompensated liver disease; or a FibroSure/FibroTest (LabCorp, Burlington, NC) result of !0.75 (unless a biopsy within 12 months excluded cirrhosis). Patients with alanine aminotransferase (ALT) >10 Â ULN, total bilirubin >2 Â ULN, or an international normalized ratio >1.2 were also excluded. Complete eligibility criteria are provided in the Supplementary Appendix.

Trauner M., Bowlus C.L., Gulamhusein A., Hameed B., Caldwell S.H., Shiffman M.L., Landis C., Muir A.J., Billin A., Xu J., Liu X., Lu X., Chung C., Myers R.P, & Kowdley K.V. (2023). Safety and Sustained Efficacy of the Farnesoid X Receptor (FXR) Agonist Cilofexor Over a 96-Week Open-label Extension in Patients With PSC. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 21(6).

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