A 24-Week Study of the Efficacy and Safety of Teduglutide in 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
- 86
- 试验地点
- 35
- 主要终点
- Responder
研究概览
简要总结
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (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. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed and dated informed consent prior to any study-related procedures are performed
- •Men and women 18 years of age or older at the time of informed consent signing
- •Intestinal failure resulting in Short Bowel Syndrome
- •At least 12 months of continuous PN dependency
- •12 weeks of clinical remission of Crohn's disease (CD) prior to dosing
- •PN required at least 3 times weekly
- •A stable PN volume for four weeks prior to dosing
排除标准
- •History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
- •Participation in clinical study within 30 days for drug or 90 days for antibody
- •Use of native GLP-2 or human growth hormone (HGH) within 6 months of screening
- •Use of iv glutamine within 30 days prior to screening
- •Use of teduglutide
- •CD patients who have been treated with biological therapy within 6 months of screening
- •IBD patients who require chronic systemic immunosuppressant therapy
- •More than 4 SBS- or PN-related hospitalizations within 12 months of screening
- •Unplanned hospitalization within one month of screening
- •Pregnant or lactating women
- •Body weight > 88kg
- •Body mass index (BMI) < 15 kg/m2
- •Severe hepatic impairment or disturbed renal function
- •Female subjects who are not surgically sterile or postmenopausal or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period
- •Not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements
- •Any condition or circumstance that is the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with the analysis of the study results
- •Significant active, uncontrolled, untreated systemic diseases
研究组 & 干预措施
Teduglutide
0.05 mg/kg/day sc dose of teduglutide
干预措施: teduglutide (Drug)
Placebo
Matching subcutaneous dose of placebo to teduglutide
干预措施: placebo (Drug)
结局指标
主要结局
Responder
时间窗: Weeks 20 and 24
Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.
次要结局
- Absolute Change in PN/I.V. Volume From Baseline to Last Time Point(Week 0 to last visit when data was collected.)