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Methods for diagnosing and evaluating non-alcoholic steatohepatitis

A steatohepatitis, non-alcoholic technology, used in biochemical equipment and methods, disease diagnosis, pharmaceutical formulations, etc., can solve problems such as unreasonable advice and trouble for patients

Active Publication Date: 2018-06-08
GENFIT SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Furthermore, liver biopsy is a very invasive procedure which can be cumbersome, worrying and painful for the patient and raises concerns of morbidity and mortality
Finally, in light of the foregoing, liver biopsy cannot reasonably be recommended as a useful tool for determining whether a person has NASH and / or for determining the activity, stage, or severity of NASH in the general population or even in patients at risk for NASH. sexual routine

Method used

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  • Methods for diagnosing and evaluating non-alcoholic steatohepatitis
  • Methods for diagnosing and evaluating non-alcoholic steatohepatitis
  • Methods for diagnosing and evaluating non-alcoholic steatohepatitis

Examples

Experimental program
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Embodiment

[0318] Sample Collection and Analysis

[0319] clinical research

[0320]The clinical trial (NASH phase 2 GOLDEN-505 trial (GFT505-212-7-NCT01694849) was a multicenter, randomized, double-blind, placebo-controlled study evaluating once-daily Elafibranor (1-[ 4-methylthiophenyl]-3-[3,5-dimethyl-4-carboxydimethylmethoxyphenyl]prop-2-en-1-one) on nonalcoholic steatohepatitis Efficacy and safety of steatohepatitis in (NASH) patients.

[0321] After appropriate exclusion of other etiologies of liver disease, a liver biopsy was performed to confirm the diagnosis of NASH. NASH was diagnosed as steatohepatitis as assessed by liver biopsy within 6 months before randomization. Confirmation of steatohepatitis was based on central reading of liver biopsy. Patients with NASH were defined as NAS ≥ 3, including steatosis grade ≥ 1, hepatocellular ballooning ≥ 1, and lobular inflammation ≥ 1.

[0322] The study was approved by the appropriate regulatory agency at each participating cen...

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Abstract

The invention relates to a method for the diagnosis of non-alcoholic steatohepatitis (NASH), for determining the activity, the stage, or the severity of NASH or for classifying a subject as a potential receiver or non receiver of a treatment of NASH using circulating miRNAs and other bood circulating markers of liver damage, e.g. alpha 2 macroglobulin, HbA1c, N-terminal pro-peptide of collagen type III, miR-34 and miR-200. It also relates to a kit for implementing the method of the invention, and the compounds for use in a method for the treatment of NASH, wherein the subject to be treated isidentified, evaluated or classified according to the method of the invention.

Description

technical field [0001] The present invention relates to a method for diagnosing non-alcoholic steatohepatitis (NASH), for determining the activity, stage or severity of NASH or for classifying a subject as a potential recipient or non-recipient of NASH treatment . The invention also relates to a kit for carrying out the method of the invention and compounds for use in the method of treating NASH, wherein the subject to be treated is identified, assessed or classified according to the method of the invention. Background technique [0002] Nonalcoholic steatohepatitis (NASH) is a progressive disease of the liver histologically characterized by fatty acid accumulation, hepatocellular injury, and alcoholic hepatitis-like inflammation. NASH is a critical stage in the progression from hepatic steatosis to cirrhosis and liver failure. Essential to establishing this diagnosis is careful confirmation that there is no history of heavy alcohol consumption. NASH is one of the most co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6883G01N33/66G01N33/72
CPCG01N33/66G01N33/723C12Q2600/178G01N2333/78G01N2333/8107C12Q2600/158C12Q1/6883A61P1/16A61K31/192G01N2800/085G01N2800/52G01N33/6893A61K31/00
Inventor 拉斐尔·达泰尔热纳维耶夫·科多尼耶约翰·布罗泽克埃米莉·普拉萨福阿德·本苏德理克
Owner GENFIT SA
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