Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 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 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. And UDCA has less effect on PBC patients whose pathology stage 3-4. Liver fibrosis might jeopardize the UDCA effect. Fuzhenghuayu is a Chinese traditional medicine for liver fibrosis and cirrhosis. Both lab research and some clinical studies suggest that Fuzhenghuayu could significantly reverse liver fibrosis and cirrhosis due to different kind of etiology. Here we start a random, open and parallel clinical research to explore the effect of Fuzhenghuayu combined with UDCA 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 or ALT > 1N) activities; c.Histological hepatic injuries consistent with PBC.
- •Had been treated with UDCA more than 6 months, and failed to achieve a complete biochemical response.
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.
- •Fuzhenghuayu anaphylaxis.
研究组 & 干预措施
Fuzhenghuayu+UDCA
Regular UDCA treatment combination with Fuzhenghuayu
干预措施: Fuzhenghuayu (Drug)
Fuzhenghuayu+UDCA
Regular UDCA treatment combination with Fuzhenghuayu
干预措施: UDCA (Drug)
Monotherapy
UDCA monotherapy
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 24
Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.
次要结局
- Change in serum transaminase level(Weeks 0, 4, 8, 12, 24, and 48)
- Change in liver biopsy examinations compared to the baseline.(Week 48)
- Change in GLOBE scores after treatment.(Week 48)
- Change in liver stiffness status measured by magnetic resonance elastography(Week 48)
- Change in serum bilirubin level(Weeks 0, 4, 8, 12, 24, and 48)
- Change in serum alkaline phosphatase (ALP) level(Weeks 0, 4, 8, 12, 24, and 48)
研究者
Han Ying
Professor Consultant Physician
Xijing Hospital of Digestive Diseases