Evaluating a blood test for diagnosing at-risk NASH
Evaluation of the Physiological Stability Variability and Robustness of NIS4,a Serum Biomarker for the Diagnosis of Non-alcoholic Steaohepatitis
This study is testing a new blood test to see if it can help identify people with non-alcoholic steatohepatitis who are at risk of serious liver damage, so they can avoid invasive procedures like liver biopsies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 88 Years |
| Sex | All |
| Sponsor | CerbaXpert Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Paris) |
| Trial ID | NCT06159257 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the physiological stability and variability of the NIS4 biomarker in patients with non-alcoholic steatohepatitis (NASH) under both fed and fasting conditions. The study focuses on patients who are at higher risk of progressing to cirrhosis, utilizing a non-invasive blood test to identify those with significant fibrosis and necroinflammation. By accurately diagnosing at-risk NASH, the trial seeks to reduce the need for invasive liver biopsies and improve patient management. The NIS4 test integrates multiple biomarkers to enhance diagnostic accuracy.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with histologically documented NASH or those with metabolic risk factors and imaging evidence of steatosis.
Not a fit: Patients with other forms of chronic liver disease or significant alcohol consumption may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for diagnosing at-risk NASH, potentially reducing unnecessary liver biopsies.
How similar studies have performed: Other studies have shown promise in using non-invasive biomarkers for diagnosing liver conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically documented steatohepatitis (NASH) with at least minimal (grade 1) hepatocyte ballooning and inflammation on a biopsy performed in the past year. * OR, if a biopsy is not available: 1. Presence of metabolic risk factors (see below) AND 2. Documentation of steatosis on imaging (hepatic ultrasound, CT scan or MRI) AND 3. Increased ALT \>30 IU/L OR liver stiffness \>5 kPa on Fibroscan * Metabolically stable condition, in particular no weight change \>5% in the past 6 months, anticipated stable diabetic therapy during the study period * No other identifiable cause of liver disease * Patients affiliated to French social security. * Written informed consent signed by the patient Exclusion Criteria: * Patient with Hepatitis B or C. * Presence of any other form of chronic liver disease * Average alcohol consumption greater than 20 g/day for females and 30 g/day for males in the preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years. * Severely uncontrolled diabetes (HbA1c\>9.5%) * Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \[\>10 days\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid). * Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline. * HIV infection. * Person not fasted 12 hours (T10, T12, D0). * Substantial diet modification in the 4 months prior to inclusion. * Patients judged by the investigator to be unsuitable for inclusion in the study (e.g., judged by the physician as unlikely to be compliant with the study protocol). * Pregnant or breastfeeding women. * Patient under legal protection measure. * Patient is a participating in another research study
Where this trial is running
Paris
- Hopital la pitié — Paris, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.