NCT06591455已完成1 期
A Single Center, Randomized Controlled, Pilot Study of Fenofibrate and Ursodeoxycholic Acid in the Treatment of Newly Diagnosed Primary Biliary Cholangitis
Han Ying1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of patients with biochemical response
研究概览
简要总结
This study is a prospective, single center, randomized controlled, exploratory clinical trial aimed at evaluating the efficacy and safety of fenofibrate in newly diagnosed PBC subjects.
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 provided written informed consent
- •Age 18-75 years;
- •BMI 17-28 kg/m2
- •Male or female with a diagnosis of PBC, by at least two of the following criteria:
- •History of AP above ULN for at least six months;
- •Positive AMA titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;
- •Documented liver biopsy result consistent with PBC.
- •Not receiving UDCA treatment before enrollment, ALP>ULN
排除标准
- •History or presence of other concomitant liver diseases.
- •ALT or AST > 5×ULN, TBIL > 3×ULN.
- •If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.
- •Allergic to fenofibrate or ursodeoxycholic acid.
- •Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.
- •Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.
- •Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).
- •Creatinine >1.5×ULN and creatinine clearance <60 ml/min.
- •Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).
- •Planned to receive an organ transplant or an organ transplant recipient.
- •Needing Liver transplantation within 1 year according to the Mayo Rick score.
- •Any other condition(s) that would compromise the safety of the subject or compromise
研究组 & 干预措施
UDCA
Active Comparator
UDCA 13-15mg/kg/day
干预措施: UDCA (Ursodeoxycholic acid) (Drug)
fenofibrate
Experimental
fenofibrate 200mg/day
干预措施: Fenofibrate (Drug)
结局指标
主要结局
Percentage of patients with biochemical response
时间窗: 6 months
The normalisation of Alkaline Phosphatase
次要结局
- Prognostic score(1, 3 and 6 month)
- Liver stiffness (LSM)(1, 3 and 6 months)
- Assessment of the pruritus(6 months)
- The changes of liver function indicators(1, 3 and 6 months)
- The percentage of patients achieving biochemical response criteria(1, 3 and 6 months)
- Event-free survival(From enrollment to the end of treatment at 6 months)
- Percentage of patients having biochemical response(1 and 3 months)
研究者
Han Ying
Professor
Xijing Hospital of Digestive Diseases
研究点 (1)
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