Safety and Efficacy of Bezafibrate Plus Ursodesoxicolic Acid in Patients With Primary Biliary Cholangitis Without Response
试验速览
- 阶段
- 3 期
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Biochemical response
研究概览
简要总结
Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation.
The main objective of the study is to evaluate safety and efficacy of bezafibrate plus ursodesoxicolic acid in patients with PBC and inadequate response to UDCA.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PBC diagnosis (consistent with American Association for the Study of Liver Disease [AASLD]:
- •History of elevated alkaline phosphatase levels.
- •Anti-mitochondrial antibodies positivity
- •Histopathologic evidence of nonsuppurative cholangitis and destruction of small or medium- sized bile ducts.
- •Use of ursodeoxycholic acid (UDCA) for at least 12 months at enrollment at a therapeutic dose (13 to 15 mg per Kg per day).
- •Evidence of a suboptimal biochemical response to UDCA, defined by the presence of one of the Paris II criteria.
- •Written informed consent.
- •Age ≥ 18 years.
排除标准
- •Hepatic decompensation (ascitis, variceal upper gastrointestinal bleeding, hepatic encephalopathy).
- •Coexistence autoimmune hepatitis.
- •Bilirrubin >3mg/dl.
- •For females, pregnancy or breast-feeding.
- •Hepatocellular carcinoma.
- •History or presence of spontaneous bacterial peritonitis.
研究组 & 干预措施
Bezafibrate and Ursodeoxycholic acid
Bezafibrate 200 mg every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.
干预措施: Bezafibrate 200 MG Oral Tablet (Drug)
Bezafibrate and Ursodeoxycholic acid
Bezafibrate 200 mg every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.
干预措施: Ursodeoxycholic Acid (Drug)
Placebo and Ursodeoxycholic acid
Placebo tablet every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.
干预措施: Placebo (Drug)
Placebo and Ursodeoxycholic acid
Placebo tablet every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.
干预措施: Ursodeoxycholic Acid (Drug)
结局指标
主要结局
Biochemical response
时间窗: 6 months
Biochemical response is defined as the reduction of alkaline phosphatase lower than 1.5 times the upper normal limit, reduction of aspartate transaminase lower than 1.5 times the upper normal limit and bilirubin lower than 1 mg/dl.
次要结局
- Quality of life(Baseline and 6 months later)
- Pruritus intensity(Baseline and 6 months later)
研究者
Jocelyn Serrano Casas
Principal Investigator
Instituto Mexicano del Seguro Social