JPRN-jRCT2080225078终止2 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 nonalcoholicsteatohepatitis (NASH) and liver fibrosis (ELIVATE) - ELIVATE
ovartis Pharma. K.K.0 个研究点目标入组 380 人开始时间: 2020年2月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 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
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Presence of NASH with fibrosis confirmed by central reader's evaluation of liver biopsy obtained no more than 6 months before randomization as demonstrated by the following:
- •1.NASH using NAFLD Activity Score (NAS) >= 4 with at least 1 point each in inflammation and ballooning and
- •2.Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria
排除标准
- •- Type 1 diabetes mellitus
- •- Uncontrolled type 2 diavetes defined as blycated hemoglobin(HbA1c) >= 9.0% 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:
- •- Platelet count < LLN (see Central laboratory manual).
- •- Serum albumin < LLN (see Central laboratory manual).
- •- International Normalized Ratio (INR) > ULN (see Central laboratory manual).
- •- ALT or AST > 5xULN(confirmed by 2 values during screening).
- •- Total billirubin > ULN(see Central laboratory manual)(confirmed by 2 values during screening), including Gilbert's syndrome.
- •- Alkaline phosphatase > 300 IU/L (confirmed by 2 values during screening).
- •- History of esophageal varices, ascites or hepatic encephalopathy
- •- Splenomegaly
- •- MELD score > 12
研究者
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