NCT06365424招募中2 期
An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
Xijing Hospital of Digestive Diseases1 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2017年4月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Percentage of patients with biochemical response
研究概览
简要总结
An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Must have given written informed consent (signed and dated)
- •Participated in the PBC study with fenofibrate (NCT02823353)
- •Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose
排除标准
- •Treatment-related adverse event (AE) leading to fenofibrate discontinuation
- •A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
- •Known history of other liver diseases
- •For females, pregnancy or breast-feeding
- •Long-term use of immunosuppressive agents
- •Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator
研究组 & 干预措施
UDCA+Fenofibrate
Experimental
干预措施: Fenofibrate (Drug)
UDCA+Fenofibrate
Experimental
干预措施: UDCA (Drug)
UDCA
Active Comparator
干预措施: UDCA (Drug)
结局指标
主要结局
Percentage of patients with biochemical response
时间窗: Through study completion, up to 120 Months
The normalisation of Alkaline Phosphatase
Treatment emergent adverse events (TEAEs)
时间窗: Through study completion, up to 120 Months
次要结局
未报告次要终点
研究者
Han Ying
Professor
Xijing Hospital of Digestive Diseases
研究点 (1)
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