Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis: a Randomized Control Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Rate of patients with complete biochemical response
研究概览
简要总结
Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (PBC) approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Both lab research and some clinical studies suggest that fenofibrate could improve cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a random, open and parallel clinical research to explore the effect of fenofibrate in the PBC treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP > 1,5N) and aminotransferase (AST/ALT > 1N) activities; c.Histological hepatic injuries consistent with PBC.
排除标准
- •Pregnancy or desire of pregnancy.
- •Breast-feeding.
- •Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis
- •History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
- •History of urolithiasis, nephritis or renal failure (clearance of creatinine < 60 ml/mn).
- •Hepatotoxic drugs use before recruiting.
- •Fenofibrate anaphylaxis.
研究组 & 干预措施
Fenofibrate + UDCA
Fenofibrate (200 mg/day) in combination with ursodeoxycholic acid (13-15 mg/kg/day)
干预措施: Fenofibrate (Drug)
Fenofibrate + UDCA
Fenofibrate (200 mg/day) in combination with ursodeoxycholic acid (13-15 mg/kg/day)
干预措施: UDCA (Drug)
Monotherapy
UDCA 13-15mg/kg/day
干预措施: UDCA (Drug)
结局指标
主要结局
Rate of patients with complete biochemical response
时间窗: Week 48
Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.
次要结局
- Change in liver biopsy examinations according to conventional Ludwig system.(Week 48)
- Change in liver stiffness status measured by magnetic resonance elastography.(Week 48)
- Change in serum levels of transaminase compared to the baseline.(Weeks 0, 4, 8, 12, 24, and 48)
- Change in serum levels of bilirubin compared to the baseline.(Weeks 0, 4, 8, 12, 24, and 48)
- Change in serum levels of ALP compared to the baseline.(Weeks 0, 4, 8, 12, 24, and 48)
- GLOBE risk scores at week 48.(Week 48)
研究者
Han Ying
Professor Consultant Physician
Xijing Hospital of Digestive Diseases