NCT01510860已完成4 期
Double-blind, Double-dummy, Randomised, Crossover, Multicentre Phase IV Clinical Study Comparing the Effect of Ursofalk 500 mg Tablets od Versus Ursofalk 250 mg Capsules od on Liver Enzymes in the Treatment of Primary Biliary Cirrhosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change of liver enzymes between baseline and the end of the treatment-period with Ursofalk 250 mg capsules and the end of treatment-period with Ursofalk 500 mg tablets.
研究概览
简要总结
The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Negative pregnancy
- •Signed informed consent
- •Histologically proven non-cirrhotic liver disease
排除标准
- •histologically proven cirrhosis
- •PBC stage II+IV
- •Positive HIV serology
研究组 & 干预措施
Ursodeoxycholic acid (UDCA)250 mg
Active Comparator
UDCA 250 mg capsule
干预措施: UDCA (Ursodeoxycholic acid) (Drug)
Ursodeoxycholic acid (UDCA)500 mg
Experimental
UDCA 500 mg tablet
干预措施: UDCA (Ursodeoxycholic acid) (Drug)
结局指标
主要结局
Change of liver enzymes between baseline and the end of the treatment-period with Ursofalk 250 mg capsules and the end of treatment-period with Ursofalk 500 mg tablets.
时间窗: Between baseline and week 24
次要结局
- Quality of Life(Between baseline and week 24)
研究者
研究点 (1)
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