Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Number of Participants With Treatment Failure
研究概览
简要总结
This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplantation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo tablet that is identical (size, color, etc) to experimental ursodeoxycholic acid tablet.
干预措施: Placebo (Drug)
Ursodeoxycholic acid
Ursodeoxycholic acid 28-30 mg/kg/day
干预措施: Ursodeoxycholic Acid (Drug)
结局指标
主要结局
Number of Participants With Treatment Failure
时间窗: 5 years
Treatment failure was defined as death, transplantation, meeting minimal listing criteria, development of varices, cholangiocarcinoma, or progression to cirrhosis
次要结局
- Number of Participants Who Have a Liver Transplantation(5 years)
- Number of Participants Who Developed Varices(5 years)
- Alkaline Phosphatase at 36 Months(36 months)
- Number of Deaths(5 years)
- Aspartate Aminotransferase at 24 Months(24 months)
- Number of Participants Meeting Minimal Listing Criteria for Liver Transplantation(5 years)
- Number of Participants Who Developed Cholangiocarcinoma(5 years)
- Alkaline Phosphatase at 24 Months(24 months)
- Number of Participants Who Developed Cirrhosis(5 years)
- Bilirubin at 12 Months(12 months)
- Bilirubin at 36 Months(36 months)
- Alkaline Phosphatase at 12 Months(12 months)
- Bilirubin at 24 Months(24 months)
- Aspartate Aminotransferase at 12 Months(12 months)
- Aspartate Aminotransferase at 36 Months(36 months)