An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Tolerability of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Primary Biliary Cirrhosis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 18
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety
研究概览
简要总结
Open-label, multicenter study in adults with Primary Biliary Cirrhosis (PBC) designed to evaluate the long-term safety and tolerability of daily dosing with LUM001.
详细描述
This is an open-label study in subjects with PBC who previously completed the LUM001 201 (CLARITY) study. The study is designed to investigate the long-term safety and tolerability of LUM001 treatment, with daily dosing for up to 2 years. Changes over time, compared to baseline, in liver enzymes, other biochemical markers associated with PBC, pruritus, and other quality of life measures will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed a core treatment protocol of LUM001 in the treatment of Primary Biliary Cirrhosis.
- •Ability to understand and willingness to sign informed consent/assent prior to initiation of any study procedures.
排除标准
- •Presence of advanced liver disease.
- •History of non-adherence during the subject's participation in the core LUM001 treatment protocol.
研究组 & 干预措施
LUM001
LUM001 administered orally once each day.
干预措施: LUM001 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety
时间窗: 2 years
Adverse events, serious adverse events, changes in vital signs, laboratory and physical exam findings, and concommitant medication usage from baseline to Week 104
次要结局
- Efficacy analysis as changes in liver enzymes and other biochemical markers from baseline to Week 104(2 years)