EUCTR2019-003932-22-DE进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
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
- •-Participants with liver biopsy fibrosis score stage 4 performed within 12 months
- •-Men and women must agree to follow methods of contraception
- •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 189
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 81
排除标准
- •-Worsening liver disease or any disease might compromise participant safety in the opinion of the investigator;
- •-Known immunocompromised status or any disease or condition which might compromise participant safety;
- •-Prior exposure to BMS-986263
- •-Clinically relevant abnormal physical examination, vital signs, ECG, or clinical laboratory tests;
- •-Hepatic decompensation.
研究者
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