A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Nonalcoholic Steatohepatitis (NASH)

Gilead Sciences, Inc.0 个研究点目标入组 125 人开始时间: 2016年12月5日最近更新: 2018年2月12日

适应症

试验速览

暂无简介。

•-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

•-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.

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