An Open-label Study of Patients with Primary Sclerosing Cholangitis (PSC) Treated with Norucholic Acid Tablets
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Occurrence of treatment emergent adverse events
研究概览
简要总结
Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- •History or presence of chronic alcoholic consumption (daily consumption > 30 g in men, > 20 g in women).
- •Patients who discontinued study participation in NUC-5/PSC due to an AE possibly caused by the study drug.
- •Liver Cirrhosis or any cirrhosis-related symptoms which in the opinion of the investigator may affect the patient's safety.
- •History of liver transplantation or patient listed for transplantation.
研究组 & 干预措施
norucholic acid 1500 mg/day
3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg
干预措施: norucholic acid (Drug)
结局指标
主要结局
Occurrence of treatment emergent adverse events
时间窗: 72 weeks from enrollment to end of treatment
Occurrence of serious treatment emergent adverse events
时间窗: 72 weeks from enrollment to end of treatment
Occurrence of severe treatment emergent adverse events
时间窗: 72 weeks from enrollment to end of treatment
Occurrence of adverse drug reactions
时间窗: 72 weeks from enrollment to end of treatment
Occurrence of unexpected treatment emergent adverse events
时间窗: 72 weeks from enrollment to end of treatment
Occurrence of treatment emergent adverse events leading to study withdrawal
时间窗: 72 weeks from enrollment to end of treatment
Occurrence of adverse events leading to death
时间窗: 72 weeks from enrollment to end of treatment
次要结局
未报告次要终点