NCT07104201进行中（未招募）1 期
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)
Xijing Hospital of Digestive Diseases2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年3月13日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Treatment emergent adverse events (TEAEs)
研究概览
简要总结
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have provided written informed consent
- •Age 18-75 years;
- •BMI 17-28 kg/m2
- •Completed in a PBC study with fenofibrate(NCT06591455)
排除标准
- •Coexisting liver disease of other etiologies, including viral hepatitis, chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis, hepatocellular carcinoma, etc.;
- •Transaminases >5 x ULN or total bilirubin >3 x ULN;
- •Pregnant or breastfeeding women, or women planning to conceive during the study period;
- •Allergy to fenofibrate or ursodeoxycholic acid;
- •Use of hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months before screening, or long-term corticosteroid use;
- •Variceal bleeding, hepatic encephalopathy, or ascites at diagnosis or previously;
- •History of severe cardiac, cerebrovascular, renal, or respiratory disease or failure, or psychiatric illness (including psychiatric illness caused by alcohol or drug abuse);
- •Creatinine >1.5 x ULN and creatinine clearance <60 mL/min;
- •Current use of statins (e.g., pravastatin, fluvastatin, simvastatin), other fibrates (e.g., gemfibrozil, bezafibrate), or structurally related drugs (e.g., ketoprofen);
- •Planned organ transplantation or previous organ transplantation;
- •Need for liver transplantation within 1 year according to the Mayo risk score;
- •Any other condition considered unsuitable for enrollment by the investigator.
研究组 & 干预措施
Fenofibrate
Experimental
Fenofibrate 200mg
干预措施: Fenofibrate (Drug)
结局指标
主要结局
Treatment emergent adverse events (TEAEs)
时间窗: Through study completion, up to 120 Months
次要结局
- Normalization of ALP(120 months)
- Death(120 months)
- Liver transplantation(120 months)
- Normalization of ALP(From enrollment to the end of treatment at 120 months)
- The changes of liver function indicators(From enrollment to the end of treatment at 120 months)
- The percentage of patients achieving biochemical response criteria(From enrollment to the end of treatment at 120 months)
- Death(From enrollment to the end of treatment at 120 months)
- Liver transplantation(From enrollment to the end of treatment at 120 months)
研究者
Han Ying
Professor
Xijing Hospital of Digestive Diseases
研究点 (2)
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