A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 88
- 试验地点
- 23
- 主要终点
- Percent Change in PN/IV Volume by Visit
研究概览
简要总结
This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.
详细描述
Some people with SBS need to infuse parenteral nutrition (PN) in order to live. Although PN can save lives, it can lead to some serious side effects such as infection or liver damage. The risk for those effects increases the longer people are on PN.
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent SBS. Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks. We also want to find out how safe teduglutide is and record any side effects.
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
- •must have completed 24 weeks of dosing of the CL0600-020 study
排除标准
- 未提供
研究组 & 干预措施
teduglutide
0.05 mg/kg/day
干预措施: teduglutide (Drug)
结局指标
主要结局
Percent Change in PN/IV Volume by Visit
时间窗: 24 months
The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
Absolute Change in PN/IV Volume by Visit
时间窗: 24 months
The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
次要结局
- Number of Subjects Achieving PN/IV Reduction(24 Months or Last Dosing Visit)