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:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT04828551
Eligibility Criteria:
Inclusion Criteria:
* Adult (age ≥ 18 years)
* Known or suspected NAFLD based on prior biopsy ≤ 36 months consistent with NAFLD OR
* Abnormal ALT (\>30 U/L for men, \> 19 U/L for women) without other common causes such as HCV, HBV, AND meets criteria within 36 months for ATP III criteria (2005 revision) for metabolic syndrome with any 3 of the 5:
Waist circumference (WC) \> 102 cm (M) or \> 88 cm (F)
* Fasting glucose ≥ 100 mg/dL or Rx
* TG≥150mg/dLorRx
* SBP \> 130 mmHg
* DBP\>85mmHg or Rx
* Able and willing to participate, including maintaining steady-state: physical activity, alcohol use, medications
* Classifiable into one of the following enrollment categories by FIB-4 (ALT, AST, platelets, date of birth) collected at screening visit if not available already within 3 months prior:
Low likelihood of advanced fibrosis: FIB-4 ≤ 1.3 (about one-third of enrolled participants, minimum 8, maximum 18), Intermediate likelihood of advanced fibrosis: 1.3 \< FIB-4 \< 2.67 (about one-third of enrolled participants, minimum 8, maximum 18), High likelihood of advanced fibrosis: FIB-4 ≥ 2.67: (about one-third of enrolled participants, minimum 8, maximum 18)
Exclusion Criteria:
* Liver disease other than NAFLD
* Excess alcohol consumption (≥ 2 units/day for women and ≥ 3 units/day for men)
* Current diagnosis of drug induced liver injury
* Receiving drug or placebo in treatment trial now or within 30 days
* Weight loss or gain of ≥ 5 kg in prior 3 months
* Other factors that in the judgment of the principal investigator might preclude study completion
* Women who state they are pregnant. Women who state they are pregnant will be excluded in an abundance of caution, since pregnancy might increase intra-abdominal pressure which in turn might affect the assessment of the different-day reproducibility coefficient of ultrasound and VCTE measurements. Women who state they might be pregnant will be required to do a urine pregnancy test to establish eligibility.
* Patients with active implants such as pacemakers or defibrillators or any other contraindication to ultrasound or VCTE scanning.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04828551
Study Brief:
Protocol Section:
NCT04828551