An investigational study to assess the safety and efficacy of a new investigational drug in subjects with Non-Alcoholic Steatohepatitis (NASH)

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders; onalcoholic steatohepatitis (NASH); Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-002496-10-AT
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-05
• Last Update Posted: 12 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

-Meets all of the following conditions:
a. A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD), and
b. Screening magnetic resonance imaging-proton density fat fraction (MRI-PDFF) with = 8% steatosis, and
c. Screening magnetic resonance elastography (MRE) with liver stiffness = 2.5 kPa
Note: criterion a. must be met before evaluating criteria b. and c. OR
d. A historical liver biopsy within 12 months of Screening consistent with NASH (defined as the presence of steatosis, lobular inflammation, and hepatocellular ballooning) with fibrosis, but not cirrhosis, and
e. No documented weight loss > 5% between the date of the liver biopsy and Screening.
Note: Screening MRI-PDFF and MRE will be performed prior to the baseline visit for all subjects including those with historical liver biopsies meeting criteria 3d.
-Platelet count = 150,000/mm^3;
-Albumin = 3.3 g/dL;
-Serum Creatinine = ULN
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

-Pregnant or lactating females;
-ALT > 5X ULN;
-Other causes of liver disease including autoimmune, viral, and alcoholic liver disease;
-Cirrhosis of the liver
-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 > 1x ULN, except with diagnosis of Gilbert’s syndrome.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified