jRCT2041260085尚未招募不适用
A Phase 3, two-part, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of efimosfermin alfa injection in adult participants with compensated cirrhosis (stage F4 fibrosis) due to metabolic dysfunction-associated steatohepatitis (NEBULA-2)
未提供0 个研究点目标入组 21 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 21
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
入排标准
- 年龄范围
- 18age old over 至 75age old under（—）
- 性别
- All
入选标准
- •Participants aged between 18 and 75 years at enrollment.
- •Participants with history or presence of at least two components of metablic syndrome.
- •Liver biopsy consistent with cirrhosis (fibrosis stage 4)
排除标准
- •Participants with other chronic liver diseases.
- •Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.
- •Participants with history of Type 1 diabetes mellitus or major Type 2 diabetes mellitus complications.
- •History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before screening.
- •A recent history or planned surgical procedures or medications intended to produce significant weight loss.
- •ALT or AST >= 5 times upper limit normal.
- •Current or history of excessive alcohol intake.
研究者
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