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Evaluation of the Physiological Stability Variability and Robustness of NIS4

NCT06159257 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-04-15

No results posted yet for this study

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.

Conditions

  • Evaluate the Physiological Stability of NIS4 Biomarker Between the Fed and Fasting State in Patients With the Target Condition (NAFLD)

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.

Sponsors & Collaborators

  • CerbaXpert

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2024-12-04
Completion
2025-09-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06159257 on ClinicalTrials.gov