NCT07197944招募中3 期
A Phase 3, Double-blind, Randomized, Parallel Group, Placebo-controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice Weekly, Followed by a Long-term, Open-label Safety Evaluation in Patients With Short Bowel Syndrome-intestinal Failure (SBS-IF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 31
- 主要终点
- Change in weekly Parenteral Support (PS) volume
研究概览
简要总结
The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data.
Glepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.
详细描述
The trial is a phase 3, double-blind, randomized, parallel-group, placebo-controlled, multicenter trial to confirm the efficacy and safety of glepaglutide 10 mg twice weekly, followed by a long-term, open-label safety evaluation in patients with short bowel syndrome-intestinal failure (SBS-IF).
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
- •Signed informed consent;
- •Age of 18 to 90 years;
- •A diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening);
- •Stable PS need of ≥3 days per week;
- •No restorative surgery planned during the trial period;
- •Having a stoma or colon in continuity.
排除标准
- •More than 2 SBS- or PS-related hospitalizations within 6 months before screening;
- •Poorly controlled Inflammatory Bowel Disease (IBD) that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial;
- •History of colorectal cancer or any other type of cancer (except for margin-free resected cutaneous basal, squamous cell carcinoma or adequately treated in situ cervical cancer) unless the patient has been disease-free for at least 5 years; ongoing bowel obstruction;
- •BMI <18.5 kg/m^2.
研究组 & 干预措施
Placebo Group
Placebo Comparator
Placebo for glepaglutide
干预措施: Placebo (Other)
Glepaglutide Group
Experimental
干预措施: Glepaglutide (Drug)
结局指标
主要结局
Change in weekly Parenteral Support (PS) volume
时间窗: Baseline to Week 24
次要结局
- Proportion of participants achieving clinical response(Baseline to Week 20 and Week 24)
- Proportion of participants with a reduction in days on PS ≥1 day/week(Baseline to Week 24)
- Proportion of participants with a reduction of 100% weekly PS volume (weaned-off)(Baseline to Week 24)
- Proportion of participants achieving 'much better' Patient Global Impression of Change (PGIC) status(Week 24)
- Change in weekly PS volume(Baseline to Week 8)
- Incidence of Treatment Emergent Adverse Events (TEAEs)(Baseline to Week 52)
- Proportion of participants achieving clinical response(Baseline to Week 52)
- Proportion of participants with a reduction in days on PS ≥1 day/week(Baseline to Week 52)
- Proportion of participants with a reduction of 100% weekly PS volume (weaned-off)(Baseline to Week 52)
- Change in weekly PS volume(Baseline to Week 12)
研究者
研究点 (31)
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