- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06159257
Evaluation of the Physiological Stability Variability and Robustness of NIS4
Evaluation of the Physiological Stability Variability and Robustness of NIS4,a Serum Biomarker for the Diagnosis of Non-alcoholic Steaohepatitis
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Paris, France
- Recruiting
- Hopital la pitié
-
Contact:
- Vlad Ratziu
- Phone Number: 0142161001
- Email: vlad.ratziu@inserm.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- 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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Steatohepatitis (NASH)
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The stability of the Non-invasive diagnostic test for steatohepatitis (NIS) 4 score and its individual components between the fed and fasting state by the the measurement of the four biomarkers involved in the calculation of NIS4 score
Time Frame: After dinner , 10 hours post-prandial and 12 hours post-prandial
|
After dinner , 10 hours post-prandial and 12 hours post-prandial
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NASH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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