A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of 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
- 106
- 试验地点
- 29
- 主要终点
- Change in Weekly Parenteral Support (PS) Volume
研究概览
简要总结
The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome.
Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
详细描述
A Phase 3, international, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of glepaglutide subcutaneous (SC) injections in patients with short bowel syndrome (SBS).
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 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 activity.
- •Diagnosis of SBS defined as remaining small bowel in continuity of estimated less than 200 cm and considered stable with regard to PS need. No restorative surgery planned in the trial period.
- •Requiring PS at least 3 days per week and maintains a stable PS volume for at least 2 weeks.
- •In case of remnant colon: documented colonoscopy which does not give rise to any safety concerns.
排除标准
- •More than 2 SBS-related or PS-related hospitalizations within 6 months prior to Screening. No SBS-related hospitalizations within 30 days prior to randomization.
- •Poorly controlled inflammatory bowel disease that is moderately or severely active or fistula interfering with measurements or examinations required in the trial.
- •Bowel obstruction.
- •Known radiation enteritis or significant villous atrophy.
- •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.
- •Clinically significant abnormal ECG.
- •Repeated systolic blood pressure measurements > 180 mm Hg.
- •Human immunodeficiency virus positive, acute liver disease, or unstable chronic liver disease.
- •Any history of colon cancer. History of any other cancers unless disease-free state for at least 5 years.
- •Estimated creatinine clearance < 30 mL/min.
- •Severe hepatic impairment.
- •Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening.
- •Use of dipeptidyl peptidase (DPP)-4 inhibitors within 3 months prior to Screening.
- •Unstable systemic immunosuppressive therapy within 3 months prior to Screening.
- •Unstable biological therapy within 6 months prior to Screening.
- •Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods.
- •Previous exposure to glepaglutide.
- •Current, or within 30 days prior to Screening, participation in another interventional clinical trial that includes administration of an active compound.
- •Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results.
研究组 & 干预措施
Glepaglutide SC injections twice weekly
Intervention: Glepaglutide
干预措施: glepaglutide (Drug)
Glepaglutide SC injections once weekly and placebo once weekly
Intervention: Glepaglutide
干预措施: glepaglutide (Drug)
Glepaglutide SC injections once weekly and placebo once weekly
Intervention: Glepaglutide
干预措施: Placebo (Drug)
Placebo SC injections twice weekly
Intervention: Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Weekly Parenteral Support (PS) Volume
时间窗: 24 weeks
Change in weekly PS volume from baseline to Week 24. Baseline actual weekly PS volume was defined as the actual PS volume derived from a valid 7-day period prior to visit 1 (Day 1), i.e. during the stabilization phase. The actual weekly PS volume at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 was derived as the actual weekly PS volume received during the valid 7-day period prior to the visit. The source for the derivation was the PS volumes recorded by the patients in the eDiary.
次要结局
- Clinical Response in PS Volume(12 and 24 weeks)
- Days Off PS(24 weeks)
- Weaned Off PS(24 weeks)
- Energy Content(24 weeks)
- Days on PS(24 weeks)
- Change in PS Volume Per Week(20 and 24 weeks)
- Patient Global Impression of Change Scale (PGIC)(24 weeks)
- Safety - Adverse Events(28 weeks)
- Number of Patients With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG)(28 weeks)
- Safety - Changes in Blood Pressure From Baseline(Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
- Safety - Changes in Body Temperature From Baseline(28 weeks)
- Immunogenicity - Occurrence of Anti-drug Antibodies(28 weeks)