A Single-Center Phase 3b Trial Investigating the Long-term Effect on Intestinal Absorption, Nutritional Status and Long-Term Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome (SBS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Absorption of Wet Weight/Fluids
研究概览
简要总结
The purpose of this trial is to investigate the long-term effect of glepaglutide on the intestinal absorption, nutritional status of participants with Short Bowel Syndrome (SBS). The trial will also investigate whether glepaglutide is safe during long-term use. All participants in the trial will receive glepaglutide injections.
Participants will have 14 visits with the study doctor. At 2 of these, participants will spend 48 hours at the trial site, one visit at the start of the trial and one after 24 weeks of treatment with glepaglutide. At all visits, participants will meet with trial staff and will have blood tests along with other clinical checks and tests done. Participants will be asked about their health and medical history.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •Age greater than or equal to 18 years and less than or equal to 90 years at screening
- •Stable condition of SBS either with intestinal failure (SBS-IF) or intestinal insufficiency. For patients with SBS-IF, a stable condition is defined as less than 25 percent change in parenteral support (PS) volume or energy content for 4 weeks prior to screening.
- •Stable body weight (less than 5 percent change in weight in the 3 months prior to screening)
- •Wet weight of fecal excretion greater than or equal to 1500 grams per day demonstrated during a hospital stay prior to screening
排除标准
- •More than 2 SBS-related or PS-related hospitalizations (e.g., catheter-related bacteremia/sepsis, bowel obstruction, severe water-electrolytes disturbances, etc.) within 6 months prior to screening
- •Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or fistula interfering with measurements or examinations required in the trial
- •Current bowel obstruction
- •Known radiation enteritis or significant villous atrophy, e.g., due to active celiac disease
- •Cardiac disease defined as: decompensated heart failure (New York Heart Association [NYHA] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to screening
- •Any history of colon cancer. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least 5 years
- •Use of glucagon-like peptide-1 (GLP-1), GLP-2, human growth hormone (HGH), somatostatin, or analogs thereof, within 3 months prior to screening
研究组 & 干预措施
once-weekly glepaglutide
All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)
干预措施: Glepaglutide (Drug)
结局指标
主要结局
Change in Absorption of Wet Weight/Fluids
时间窗: from Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
次要结局
- Change in Absorption of Energy(from Week 0 (baseline) to Week 24)
- Change in Absorption of Carbohydrates(from Week 0 (baseline) to Week 24)
- Change in Absorption of Lipids(from Week 0 (baseline) to Week 24)
- Change in Absorption of Proteins(from Week 0 (baseline) to Week 24)
- Change in Absorption of Sodium(from Week 0 (baseline) to Week 24)
- Change in Absorption of Potassium(from Week 0 (baseline) to Week 24)
- Change in Absorption of Calcium(from Week 0 (baseline) to Week 24)
- Change in Absorption of Magnesium(from Week 0 (baseline) to Week 24)
- Change in Weekly Parenteral Support (PS) Volume(from Week 0 (baseline) to Week 12)
- Change in Weekly PS Volume(from Week 0 (baseline) to Week 24)
- Change in Weekly PS Carbohydrates(from Week 0 (baseline) to Week 24)
- Change in Weekly PS Lipids(from Week 0 (baseline) to Week 24)
- Change in Weekly PS Proteins(from Week 0 (baseline) to Week 24)
- Change in Weekly PS Sodium(from Week 0 (baseline) to Week 24)
- Change in Weekly PS Potassium(from Week 0 (baseline) to Week 24)
- Change in Weekly PS Magnesium(from Week 0 (baseline) to Week 24)
- Anti-glepaglutide Antibodies(Week 56)
- Reactivity to ZP1848(Week 56)
- Cross-reactivity to Glucagon-like Peptide-2 (GLP-2)(Week 56)
- Glepaglutide Neutralizing Antibodies(Week 56)