A Pilot Study of Xifaxan in Patients With Primary Sclerosing Cholangitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Improvement in alkaline phosphatase
研究概览
简要总结
In the current protocol, we propose the assessment of potential beneficial effects of the antibiotic Xifaxan on liver biochemistries, liver related symptoms and Mayo risk score in 15 adult and 5 pediatric patients with PSC. Adult patients will receive Xifaxan, 550 mg twice daily over a 12-week period. Pediatric patients with PSC whose weight is greater than or equal to 40 kg will receive Xifaxan, 550 mg twice daily.
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 75 Years（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
- 未提供
研究组 & 干预措施
Xifaxan
Xifaxan 550 mg two times per day for three months
干预措施: Xifaxan (Drug)
结局指标
主要结局
Improvement in alkaline phosphatase
时间窗: Three months
An improvement in elevated levels of alkaline phosphatase to less than half of the initial level at study entry
Absence of treatment failure
时间窗: Three months
Absence of treatment failure which is defined as any of the following: death, need for liver transplantation, side effects requiring discontinuation of therapy, worsening of liver biochemistries, voluntary discontinuation for any reason, marked worsening of fatigue or itching.
次要结局
未报告次要终点
研究者
Jayant A. Talwalkar
Principal Investigator
Mayo Clinic