Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 303
- 试验地点
- 2
- 主要终点
- superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)
研究概览
简要总结
Double-blind, randomized, multi-center, placebo-controlled, comparative, phase III trial. The study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules for the treatment of Primary Sclerosing Cholangitis.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •verified PSC
- •Liver Biopsy available for Review
- •If pre-treated with UDCA Patient must be on stable dose not exceeding 20mg/kg/bw
- •Patients with or without concomittant IBD
排除标准
- •History or presence of other concomitant liver diseases
- •Presence of Cholangiocarcinoma
- •Secondary causes of Sclerosing Cholangitis
- •Small Duct Cholangitis in the absence of large duct disease
- •Any known relevant infectious disease
- •Abnormal renal function
- •Any active malignant disease
- •Known intolerance/hypersensitivity to study drug
研究组 & 干预措施
norUrsodeoxycholic acid
norUrsodeoxycholic acid 250mg capsules, 6 capsules/day for 2 years
干预措施: norUrsodeoxycholic Acid (Drug)
Placebo to norUrsodeoxycholic acid
norUrsodeoxycholic acid 250mg Placebo-capsules, 6 capsules/day for 2 years
干预措施: norUrsodeoxycholic Acid (Drug)
结局指标
主要结局
superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)
时间窗: 2 years
prevention of disease progression assessed by partial normalization of serum Alkaline Phosphatase (s-ALP) levels in patients with PSC
Show superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)
时间窗: 2 years
prevention of disease progression assessed by liver histology
次要结局
未报告次要终点