Status:
RECRUITING
Evaluation of the Physiological Stability Variability and Robustness of NIS4
Lead Sponsor:
CerbaXpert
Conditions:
Evaluate the Physiological Stability of NIS4 Biomarker Between the Fed and Fasting State in Patients With the Target Condition (NAFLD)
Eligibility:
All Genders
18-88 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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:
- Presence of metabolic risk factors (see below) AND
- Documentation of steatosis on imaging (hepatic ultrasound, CT scan or MRI) AND
- 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
- 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
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 5 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06159257
Start Date
September 5 2023
End Date
September 5 2025
Last Update
April 15 2024
Active Locations (1)
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1
Hopital la pitié
Paris, France