EUCTR2019-002324-32-ES进行中（未招募）1 期
A randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor (LJN452) & licogliflozin (LIK066) combination therapy, compared to each monotherapy, for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis (ELIVATE)
ovartis Farmacéutica, S.A.0 个研究点目标入组 210 人开始时间: 2019年11月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Presence of NASH as demonstrated by the following: NASH with fibrosis stage 2 or 3 confirmed by central reader's evaluation using NAFLD Activity Score (NAS) and NASH CRN criteria, of liver biopsy obtained no more than 6 months before randomization.
- •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 165
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •Type 1 diabetes mellitus
- •Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) = 9.5% at screening
- •HbA1c < 6.5% at screening in Type 2 diabetics currently treated with insulin or sulfonylureas
- •Clinical evidence of liver impairment as defined by the presence of any of the following abnormalities:
- •?Abnormal platelet count
- •?Serum albumin < 3.2g/dL
- •?International Normalized Radio (INR) > 1.3
- •?ALT or AST > 5xULN
- •?Total bilirubin >1.3 mg/dL (22 µmol/L) (including Gilbert's syndrome)
- •?Alkaline phosphatase > 300 IU/L
- •?History of esophageal varices, ascites or hepatic encephalopathy
- •?Splenomegaly
研究者
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