NCT06174402进行中（未招募）2 期
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis
Han Ying12 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2023年8月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 184
- 试验地点
- 12
- 主要终点
- Percentage of patients with biochemical response
研究概览
简要总结
The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 alkaline phosphatase（ALP） above upper limit of normal（ULN） for at least six months;
- •Positive Anti-mitochondrial antibody (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.
- •Incomplete response to UDCA defined by 1 ULN< ALP <= 1.67 ULN
- •Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0
排除标准
- •History or presence of other concomitant liver diseases.
- •ALT or AST > 5×ULN, total bilirubin（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
Placebo-UDCA
Placebo Comparator
1 tablet/ day and UDCA 13-15mg/kg/day for 12 months
干预措施: Placebo (Drug)
Fenofibrate-ursodesoxycholic acid（UDCA）
Experimental
Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months
干预措施: UDCA (Drug)
Placebo-UDCA
Placebo Comparator
1 tablet/ day and UDCA 13-15mg/kg/day for 12 months
干预措施: UDCA (Drug)
Fenofibrate-ursodesoxycholic acid（UDCA）
Experimental
Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months
干预措施: Fenofibrate (Drug)
结局指标
主要结局
Percentage of patients with biochemical response
时间窗: 48 weeks
The normalisation of Alkaline Phosphatase
次要结局
- Percentage of patients having biochemical response(4, 12, 24 and 36weeks)
- Percentage of patients having biological or clinical adverse events(4, 12, 24, 36, and 48 weeks)
- Survival without transplantation and hepatic impairment(48 weeks)
- Assessment of the pruritus(4, 12, 24, 36, and 48 weeks)
- Assessment of the fatigue(4, 12, 24, 36, and 48 weeks)
- Changes in biochemical indicators compared to baseline(4,12,24,36 and 48 weeks)
- Prognostic score(48 weeks)
- Changes in liver stiffness(48 weeks)
研究者
Han Ying
Professor
Xijing Hospital of Digestive Diseases
研究点 (12)
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