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RECRUITING
NCT06159257
NA

Evaluation of the Physiological Stability Variability and Robustness of NIS4

Sponsor: CerbaXpert

View on ClinicalTrials.gov

Summary

Patients at higher risk of progression to cirrhosis and clinical deleterious outcomes are those that have a high grade of necroinflammation together with significant fibrosis. This defines a level of disease severity which is called "at-risk NASH". Currently registrational trials for NASH include only patients with at-risk NASH so it is predictable that when a drug will be approved for NASH it will be in patients with at-risk NASH. It is therefore important to be able to diagnose non-invasively patients with at-risk NASH. Also, the use of NIS4 in clinical trials or in the clinic has the potential to significantly reduce unnecessary liver biopsies by identifying patients with a lower risk of disease progression. GENFIT, a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and chronic liver diseases, is developing an in vitro diagnostic test for at-risk NASH. The test is calledNIS4™ and integrates four independent biomarkers - miR-34a-5p, A2M, YKL-40 and HbA1c. The output is a score from 0 to 1 with threshold values that identify patients at low risk and high risk of at-risk NASH with intermediate values representing indeterminate results. The objective of the program is to complete the development of the predictive and usable NIS4 score and to evaluate the impact of fasting or not fasting on the physiological stability, variability and robustness of circulating biomarkers for the diagnosis of non-alcoholic steatohepatitis over a 30-day period.

Official title: Evaluation of the Physiological Stability Variability and Robustness of NIS4,a Serum Biomarker for the Diagnosis of Non-alcoholic Steaohepatitis

Key Details

Gender

All

Age Range

18 Years - 88 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-09-05

Completion Date

2025-09-05

Last Updated

2024-04-15

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Blood test

Whenever possible, samples will be collected by the nurse in the patient's home, according to the study visit schedule. However, if this is not possible, patients will be asked to come in for sample collection at another mutually convenient time at the CERBA ALLIANCE LABORATORY closest to the patient's address. Venous blood will be drawn on each visit.

Locations (1)

Hopital la pitié

Paris, France