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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT02854605
Eligibility Criteria:
Key Inclusion Criteria:
* Meets the following conditions:
* A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)
* Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF) with ≥ 8% steatosis
* Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5 kilopascal (kPa) OR
* A historical liver biopsy within 12 months of screening consistent with NASH with fibrosis, but not cirrhosis, and
* No documented weight loss \> 5% between the date of the liver biopsy and screening.
* Platelet count ≥ 150,000/mm\^3
* Albumin ≥ 3.3 g/dL
* Serum creatinine ≤ upper limit of normal (ULN)
Key Exclusion Criteria:
* Pregnant or lactating females
* Alanine aminotransferase (ALT) \> 5x upper limit of the normal range (ULN)
* Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
* Cirrhosis of the liver
* Prior history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding
* Body mass index (BMI) \< 18 kg/m\^2
* Uncontrolled diabetes mellitus (hemoglobin A1c \> 9% at screening)
* International normalized ratio (INR) \> 1.2 unless on anticoagulant therapy
* Total bilirubin \> 1 x ULN, except with diagnosis of Gilbert's syndrome
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02854605
Study Brief:
Protocol Section:
NCT02854605