2024-512486-14-00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)
Zealand Pharma A/S1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2025年12月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- 1. Change in weekly PS volume from baseline to Week 24
研究概览
简要总结
To confirm the efficacy of glepaglutide 10 mg TW in patients with SBS-IF
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase III
- 盲法
- Double (Subject, Monitor, Carer, Investigator, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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 IBD that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial;
- •a 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/m2.
结局指标
主要结局
1. Change in weekly PS volume from baseline to Week 24
1. Change in weekly PS volume from baseline to Week 24
次要结局
- 1. Clinical response, defined as achieving a reduction of at least 20% in weekly PS volume from baseline to Week 52
- 2. Reduction in days on PS ≥1 day/week from baseline to Week 52
- 3. Reduction of 100% weekly PS volume (weaned-off) from baseline to Week 52
- 4. Achieving ‘much better’ PGIC status at Week 24
- 5. Clinical response, defined as achieving at least 20% reduction in weekly PS volume from baseline to both Week 20 and Week 24
- 6. Reduction in days on PS ≥1 day/week from baseline to Week 24
- 7. Reduction of 100% weekly PS volume (weaned-off) from baseline to Week 24
- 8. Change in weekly PS volume from baseline to Week 12
- 9. Change in weekly PS volume from baseline to Week 8
- 10. TEAEs from baseline to Week 52
研究者
Clinical Trial Information Desk
Scientific
Zealand Pharma A/S
研究点 (1)
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