Effect of Simvastatin on the Prognosis of Primary Sclerosing Cholangitis (PSC); A Randomized, Double-blind, Placebo Controlled Multicenter Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 571
- 试验地点
- 12
- 主要终点
- Overall survival
研究概览
简要总结
This is a randomized, double-blind, placebo controlled multicenter study.
A total of 700 patients will be included. After an updated powercalculation 560 was condidered enough
The study will include patients with primary sclerosing cholangitis (PSC) for daily intake of 40 mg simvastatin/placebo for 5 years. The aim is to study effect of prognosis of PSC by long term intake of simvastatin. Outcome measures are death, liver transplantation, cholangiocarcinoma or bleeding from esophageal varices.
Subjects will be randomized (1:1) between Simvastatin and placebo.
详细描述
Please see published protocol
Long Term Effect of Simvastatin in Primary Sclerosing Cholangitits: A Placebo-Controlled, Double-Blind, Multicenter Phase III Study (Piscatin)
A. Bergquist, H. U. Marschall, E. Nilsson, N. Nyhlin, M. Werner, A. Klein, et al.
British Journal of Gastroenterolgy 2022 Vol. 1 Pages 235-241.
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
- •PSC verified by cholangiography or liver biopsy, with or without irritable bowel disease (IBD).
- •Men and women between ≥18 years and ≤75 years.
- •Written informed consent.
- •A magnetic resonance imaging (MRI) or Magnetic resonance cholangiopancreatography (MRCP) performed within 4 months prior to randomization.
- •Colonoscopy performed within 24 months prior to randomization, if known IBD.
- •For women of childbearing potential efficient contraceptive.
排除标准
- •Subjects on waiting list for transplantation
- •Transplanted subjects
- •Previous variceal bleeding
- •Previous hepatobiliary malignancy
- •Subjects with secondary sclerosing cholangitis
- •Intake of any type of statins within 3 months prior to randmization
- •Known intolerance to simvastatin.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Simvastatin
Simvastatin 40 mg administered orally daily for 5 years.
干预措施: Simvastatin 40mg (Drug)
Placebo
Placebo for Simvastatin 40 mg administered orally daily for 5 years.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Overall survival
时间窗: Time from the date of randomization to the date of death, assessed up to 5 years.
Overall survival from time to randomization to death from any cause.
Time to diagnosis of cholangiocarcinoma, gall bladder cancer, or hepatocellular cancer.
时间窗: Time from the date of randomization to cancer diagnosis, assessed up to 5 years.
Diagnosis of cancer of bile duct cancer or gall bladder, or hepatocellular cancer according to hospital patient records.
Time to first varices bleeding
时间窗: Time from the date of randomization to the date of the first varices bleeding, assessed up to 5 years.
Date of the subject's first varices bleeding according to hospital patient records.
Listing for liver transplantation
时间窗: Time from the date of randomization to the date of listing for liver transplantation, assessed up to 5 years.
Date the subject is getting registered on the waiting list for liver transplantation.
次要结局
- Effect on the progress of PSC by liver failure measurement(Assessed at every visit except the 3 months visit, up to 5 years.)
- Effect on serum concentration of bilirubin(Assessed yearly up to 5 years.)
- Effect on serum concentration of alkaline phosphatase (ALP).(Assessed yearly up to 5 years.)
- Effect on the progress of PSC by liver failure measurement.(Assessed at every visit except the 3 months visit, up to 5 years.)
- Effect on the progress of PSC assessed by elastography(Assessed yearly up to 5 years.)
- Effect on the progress of PSC assessed by measurement of biliary dysplasia(Assessed upon clinical indication, up to 5 years.)
- Effect on the development of colon cancer or colon dysplasia.(Assessed at 60 months.)
- Effect on the progress of PSC assessed by clinical symptoms(Assessed yearly up to 5 years.)
- Effect on the progress of PSC assessed by cholangiography at MRI.(Assessed at inclusion and the 60 months visit.)
- Effect on the progress of PSC assessed by serum fibrosis markers(Assessed yearly up to 5 years)
研究者
Annika Bergquist
Professor
Karolinska University Hospital