CTIS2024-513584-77-00进行中（未招募）1 期
A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination with Obeticholic Acid in Subjects with Primary Biliary Cholangitis - 747-214
Intercept Pharmaceuticals Inc.0 个研究点目标入组 60 人开始时间: 2024年6月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •A define or probable diagnosis of PBC, Qualifying ALP and/or bilirubin liver biochemistry values, Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1
排除标准
- •History or presence of other concomitant liver diseases, Presence of clinical complications of PBC, History or presence of decompensating events, Current or history of gallbladder disease, If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating., Treatment with commercially available OCA or participation in aprevious study involving OCA within 3 months before Screening, Treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening
研究者
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