EUCTR2019-002324-32-SK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 and each monotherapy, compared with placebo for treatment of adult participants with nonalcoholic steatohepatitis (NASH) and liver fibrosis (ELIVATE)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 380
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
- 性别
- All
入选标准
- •Presence of NASH with fibrosis as confirmed by central reader's evaluation of liver biopsy obtained no more than 6 months before randomization. demonstrated by the following:
- •- NASH using NAFLD Activity Score (NAS) >= 4 with at least 1 point each in inflammation and ballooning
- •- Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria
- •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 325
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •Type 1 diabetes mellitus
- •Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) = 9% 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 < LLN (see central lab manual)
- •?International Normalized Radio (INR) > ULN
- •?ALT or AST > 5xULN (in either of the 2 values)
- •?Total bilirubin > ULN (see central lab manual) (including Gilbert's syndrome)
- •?Alkaline phosphatase > 300 IU/L (in either of the 2 values during screening)
- •?History of esophageal varices, ascites or hepatic encephalopathy
- •?Splenomegaly
研究者
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