CTRI/2020/08/027184招募中2 期
â??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)â??
ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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 readers evaluation using NAFLD Activity Score(NAS)and NASH CRN criteria,of liver biopsy obtained no more than 6 months before randomization.
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
- •Alkaline phosphatase > 300 IU/L
- •History of esophageal varices, ascites or hepatic encephalopathy
- •Splenomegaly
研究者
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