NCT06488911终止3 期
A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects With Primary Biliary Cholangitis
Intercept Pharmaceuticals102 个研究点 分布在 16 个国家目标入组 62 人开始时间: 2024年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 102
- 主要终点
- Number of participants reporting adverse events (AE) and serious adverse event (SAE)
研究概览
简要总结
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).
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
- •All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 are eligible to enroll in this study (977-311).
排除标准
- •History or presence of other concomitant liver diseases
- •Clinical complications of PBC
- •History or presence of hepatic 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.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
OCA 5 mg + BZF 400 mg SR
Experimental
Participants will be administered with OCA 5 mg + BZF 400 mg SR once daily.
干预措施: FDC tablet (OCA 5 mg + BZF 400 mg SR) (Drug)
结局指标
主要结局
Number of participants reporting adverse events (AE) and serious adverse event (SAE)
时间窗: Up to 60 months
次要结局
- Number of participants with 50 percent (%) reduction of pruritus determined by visual analogue scale (VAS) score(Up to 60 months)
- Number of participants with Adjudicated Liver Related Clinical Outcomes - Progression to hepatic decompensation(Up to 60 months)
- Number of participants reporting all-cause mortality(Up to 60 months)
- Number of participants with Adjudicated Liver Related Clinical Outcomes - Liver transplant(Up to 60 months)
- Number of participants with Adjudicated Liver Related Clinical Outcomes - Model for End-Stage Liver Disease (MELD) Score ≥15(Up to 60 months)
研究者
研究点 (102)
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