A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy 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
- 150
- 试验地点
- 27
- 主要终点
- Safety - Adverse Events
研究概览
简要总结
The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS).
Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.
详细描述
A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide 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
- •Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073)
排除标准
- •Withdrawal of consent from the lead-in trial
- •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
- •Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 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
研究组 & 干预措施
Glepaglutide SC injections twice weekly
Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly.
In this long term safety study, there is no placebo arm.
干预措施: glepaglutide (Drug)
Glepaglutide SC injections once weekly and placebo once weekly
Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection once weekly and placebo once weekly.
In this long term safety study, there is no placebo arm.
干预措施: glepaglutide (Drug)
结局指标
主要结局
Safety - Adverse Events
时间窗: 2 years
Incidence and type of Adverse Events
次要结局
- Safety - Changes in blood pressure from baseline(2 years)
- Number of patients with clinically significant changes in 12-Lead electrocardiogram (ECG)(2 years)
- Energy content (amino acids)(2 years)
- Safety - Serious Adverse Events(2 years)
- Immunogenicity - Occurrence of anti-drug antibodies(2 years)
- Number of patients with 40 percent change in PS volume per week(2 years)
- Change in weekly Parenteral Support (PS) volume(2 years)
- Days off PS(2 years)
- Weaned off PS(2 years)
- Energy content (lipids)(2 years)
- Days on PS(2 years)
- Safety - Adverse Events of Special Interest(2 years)
- Number of patients with 20 percent reduction in PS volume(2 years)
- Changes in fluid composite effect(2 years)
- Energy content (glucose)(2 years)