Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT04800094
Eligibility Criteria:
Inclusion Criteria:
* Subjects at least 5 years old up through and including 21 years old who are able to provide informed consent to participate or have a legal representative/parent/legal guardian who is able to provide informed consent for the subject to participate.
* Subjects must be eligible for a standard abdominal ultrasound examination and standard non-contrast MRI examination.
In addition, at least one of the following criteria must also be met:
* Overweight or obese (BMI-for-age ≥ 85th percentile).
* Diagnosed with Type 2 diabetes per standard clinical guidelines.
* Diagnosed with hypercholesterolemia per standard clinical guidelines.
* Diagnosed with or clinically suspected of having NAFLD/NASH based on previous medical record, medical imaging, liver biopsy, and/or laboratory testing.
Exclusion Criteria:
* History of moderate/heavy/binge alcohol consumption exceeding NIAAA guidelines.
* Evidence of hepatotoxicity or cirrhosis in the clinical judgment of the investigator.
* History of chronic liver disease other than NAFLD (e.g., viral, cholestatic, or autoimmune).
* Use of drugs associated with hepatic steatosis:
* Amiodarone
* Methotrexate
* Nucleoside reverse transcriptase inhibitors (didanosine, stavudine)
* Valproic acid
* Dexamethasone
* Tamoxifen
* 5-FU-based adjuvant chemotherapy
* Apo-B inhibitors (mipomersen, lomitapide)
* Tetracycline exceeding 2 g/day
* Acetylsalicylic acid exceeding 150 mg/kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
21 Years
Study:
NCT04800094
Study Brief:
Protocol Section:
NCT04800094