EUCTR2018-002575-17-HR进行中（未招募）1 期
A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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
- •- A definite or probable diagnosis of PBC (consistent with the EASL and the AASLD guidelines [Lindor 2009a, EASL 2017])
- •- Qualifying ALP and/or bilirubin liver biochemistry values
- •- Age =18 years
- •- Taking UDCA for at least 12 months (stable dose for =3 months) before Day 1 or no UDCA for 3 months before Day 1
- •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 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- History or presence of other concomitant liver diseases
- •- Clinical complications of PBC
- •- History or presence of decompensating events
- •- History of or current gallbladder diseases
- •- 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 a previous study involving OCA
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究者
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