jRCT2031230056招募中不适用
A Phase 2, Multicenter, Placebo-Controlled, Randomized, Double-Blind, 48-Week Study to Evaluate the Efficacy and Safety of Combination Therapy of K-877-ER and CSG452 in Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Liver Fibrosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 主要终点
- improvement from Baseline in disease activity and no worsening of liver fibrosis
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Able to understand and comply with study procedures and give written informed consent
- •Age >=18 years
- •NAS >=4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization
- •Fibrosis stage of 1 or greater and below 4 on NASH CRN (Clinical Research Network) fibrosis staging system at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization
排除标准
- •Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study
- •Ongoing or recent consumption of significant amounts of alcohol as defined in clinical study protocol
- •Evidence of other forms of chronic liver disease as defined in clinical study protocol
结局指标
主要结局
improvement from Baseline in disease activity and no worsening of liver fibrosis
时间窗: Week 48
The improvement in disease activity is defined as improvement in NAFLD Activity Score (NAS) >=2 points. The worsening of fibrosis is defined as any numerical increase in the stage.
次要结局
未报告次要终点
研究者
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