A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 65
- 试验地点
- 21
- 主要终点
- Number of Subjects Achieving a 20% Reduction at Week 28
研究概览
简要总结
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
详细描述
Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).
This multicenter, double-blind, international, Phase III trial will have a treatment period of 28 weeks. Subjects in this study are those who received teduglutide or placebo in protocol CL0600-004 (NCT00081458). These subjects will receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight. Subjects will have visits every 4 to 6 weeks and will be assessed for parenteral nutrition (PN) reduction with a follow-up period of 4 weeks duration for those subjects who do not complete this protocol, or do not enter into the long-term safety extension protocol CL0600-010.
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
- Triple (Participant, Care Provider, Investigator)
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
- •At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study.
- •Subjects who meet all of the following criteria can be enrolled in this study:
- •Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed
- •Completion of protocol CL0600-004 (NCT00081458)
排除标准
- •History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
- •History of alcohol or drug abuse (within previous year)
- •Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit
- •Pregnant or lactating women
- •Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results
研究组 & 干预措施
teduglutide 0.05 mg/kg/d
0.05 mg/kg/d teduglutide subcutaneous injection
干预措施: teduglutide 0.05 mg/kg/d (Drug)
teduglutide 0.10 mg/kg/d
0.10 mg/kg/d teduglutide subcutaneous injection
干预措施: teduglutide 0.10 mg/kg/d (Drug)
结局指标
主要结局
Number of Subjects Achieving a 20% Reduction at Week 28
时间窗: 28 weeks
For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use. For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use.
次要结局
- Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use(6 months)