NCT05749822招募中2 期
Fenofibrate Combined With Ursodeoxycholic Acid in Compensated Cirrhosis Patients With Primary Biliary Cholangitis Who Had an Inadequate Response to Ursodeoxycholic Acid
Xijing Hospital of Digestive Diseases12 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2023年2月17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
- 招募中
- 发起方
- 入组人数
- 104
- 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).
详细描述
This is a multi-center, randomized, placebo-controlled, parallel-group study that aims to assess the efficacy and safety of fenofibrate in patients with compensated cirrhosis PBC who had an inadequate biochemical response to UDCA. Fenofibrate or placebo 200 mg will be daily administered in combination with UDCA 13-15 mg/kg/d for 12 months.
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 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.
- •Diagnosis of compensated cirrhosis, as demonstrated by the presence of ≥ 1 of the following 4 diagnostic factor
- •The histology was consistent with the diagnosis of liver cirrhosi;
- •Endoscopy shows esophageal and gastric varices or ectopic varices of digestive tract, excluding non cirrhotic portal hypertension;
- •Ultrasound or CT and other imaging examinations indicate the characteristics of liver cirrhosis or portal hypertension, such as splenomegaly, portal vein ≥ 1.3 cm, or liver stiffness measured by transient elastography>16.9 kPa;
- •Abnormal laboratory inspection indicators (2 out of 4): 1) PLT < 100 × 109/L, and no other reason can be explained; 2) Serum albumin<35 g/L, excluding malnutrition or kidney disease and other causes; 3) INR > 1.3 or PT prolongation (stop thrombolytic or anticoagulant drugs for more than 7 days); 4) AST/PLT (APRI)>2）
- •Incomplete response to UDCA defined by ALP > 1.67 x 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, 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)
Placebo-UDCA
Placebo Comparator
1 tablet/ day and UDCA 13-15mg/kg/day for 12 months
干预措施: UDCA (Drug)
Fenofibrate-UDCA
Experimental
Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months
干预措施: Fenofibrate 200mg (Drug)
Fenofibrate-UDCA
Experimental
Fenofibrate 200 mg/day and UDCA 13-15mg/kg/day for 12 months
干预措施: UDCA (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)
- Assessment of the pruritus and fatigue(4, 12, 24, 36, and 48 weeks)
- Survival without transplantation and hepatic impairment(48 weeks)
- Percentage of patients having biological or clinical adverse events(4, 12, 24, 36, and 48 weeks)
研究者
Han Ying
Professor
Xijing Hospital of Digestive Diseases
研究点 (12)
Loading locations...
相似试验
进行中（未招募）
2 期
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary CholangitisPrimary Biliary CholangitisNCT06174402Han Ying184
已完成
4 期
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis PatientsPeritoneal Dialysis ComplicationHypoalbuminemiaHyperphosphatemiaNCT04046263University of Colorado, Denver17
撤回
2 期
Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary CirrhosisPrimary Biliary CirrhosisNCT01141296University of Miami
已完成
不适用
Evaluation of Possible Safety and Efficacy of Fenofibrate in the Prophylaxis of Doxorubicin Induced Cardiotoxicity in Breast Cancer PatientsBreast Cancer Stage 2 and 3NCT06155331Tanta University44
已完成
2 期
Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid ArthritisRheumatoid ArthritisNCT05973370Tanta University60