NCT00004842已完成1 期
Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 1997年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in serum alkaline phosphatase
研究概览
简要总结
OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid.
II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating the feasibility of a long-term randomized trial.
详细描述
PROTOCOL OUTLINE:
Patients receive budesonide by mouth 3 times daily for a minimum of 6 months. If liver biochemistries become normal, dosage is reduced to once daily. Treatment discontinues after 1 year.
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 70 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
Budesonide
Experimental
Oral budesonide
干预措施: budesonide (Drug)
结局指标
主要结局
Change in serum alkaline phosphatase
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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