NCT02026401已完成2 期
A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Activity of NGM282 in Combination With Ursodeoxycholic Acid (UDCA) Administered for 28 Days in Patients With Primary Biliary Cirrhosis
NGM Biopharmaceuticals, Inc17 个研究点 分布在 2 个国家目标入组 45 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 17
- 主要终点
- Absolute change in plasma ALP from Baseline to Day 28
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, between 18 and 75 years of age, inclusive
- •PBC diagnosis consistent with AASLD and EASL guidelines
- •Stable dose of UDCA
排除标准
- •Chronic liver disease of a non-PBC etiology
- •Evidence of clinically significant hepatic decompensation
结局指标
主要结局
Absolute change in plasma ALP from Baseline to Day 28
时间窗: 28 days
次要结局
- Absolute change in bilirubin from Baseline to Day 28(28 days)
研究者
研究点 (17)
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