NCT01755507已完成2 期
Double-blind,Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of Norursodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 3
- 主要终点
- Change in serum AP levels during treatment
研究概览
简要总结
Evaluation of the efficacy of different doses of nor UDCA vs. placebo for the treatment of Primary Sclerosing Cholangitis (PSC). Identification of optimal dose(s)for the treatment of PSC.
详细描述
Double-blind, randomized, multi-center, placebo-controlled, comparative exploratory phase II-finding trial.The study will be conducted with four treatment groups in the form of a parallel-group comparison and will serve to compare oral treatment with either 500 mg/d, 1000 mg/d or 1500 mg/d norursodeoxycholic acid capsules vs. Placebo capsules for the treatment of PSC.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Verified diagnosis of PSC
- •PSC patients with or without IBD
- •Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control.
排除标准
- •History or presence of other concomitant liver diseases
- •Treatment with UDCA within 8 weeks prior to baseline visit.
- •Child B/C liver cirrhosis
- •Total bilirubin > 3.0 mg/dl at screening or baseline.
- •Any relevant systemic disease
- •TSH>ULN at screening
- •any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder
- •Any active malignant disease
- •Known intolerance/hypersensitivity to study drug
- •Existing or intended pregnancy of brest feeding
- •Simultaneous participation in another clinical trial
研究组 & 干预措施
placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
C
Experimental
norUDCA
干预措施: norUDCA (Drug)
B
Experimental
norUDCA
干预措施: norUDCA (Drug)
A
Experimental
norUDCA
干预措施: norUDCA (Drug)
结局指标
主要结局
Change in serum AP levels during treatment
时间窗: 12 weeks
次要结局
- Proportion of patients with at least 50% reduction in s-ALP(12 weeks)
研究者
研究点 (3)
Loading locations...
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