NCT04627025已完成3 期
A Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Apraglutide in Adult Subjects With Short Bowel Syndrome and 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
- 已完成
- 发起方
- VectivBio AG
- 入组人数
- 164
- 试验地点
- 68
- 主要终点
- Relative change from baseline in actual weekly PS volume at Week 24.
研究概览
简要总结
The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.
详细描述
This is an international, multicenter, double-blind, randomized, placebo-controlled, trial to evaluate the efficacy and safety of weekly SC injections of apraglutide in adult subjects with SBS-IF. The active pharmaceutical ingredient is apraglutide, a GLP-2 analogue.
The trial consists of a screening phase, a treatment phase of 48 weeks, and a safety follow-up phase. Trial participants will receive, after successful screening, once weekly apraglutide.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Pregnancy or lactation.
- •Major abdominal surgery in the last 6 months prior to screening.
- •History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.
- •Evidence of active inflammatory GI conditions in the previous 6 months.
- •Evidence of decompensated heart failure.
- •Evidence of severe renal or hepatic impairment.
- •Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.
研究组 & 干预措施
Apraglutide SC injections, once weekly
Experimental
Peptide analogue of GLP-2
干预措施: apraglutide (Drug)
Placebo
Placebo Comparator
Placebo for apraglutide, SC injection once weekly
干预措施: apraglutide (Drug)
结局指标
主要结局
Relative change from baseline in actual weekly PS volume at Week 24.
时间窗: At week 24 of treatment
次要结局
- Subjects who achieve a reduction of at least 1 day per week of PS at Weeks 24 / 48 (CIC only).(Weeks 24 and 48 of treatment)
- Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48 (CIC only).(Weeks 12 / 24 / 48 of treatment)
- Subjects reaching enteral autonomy at Weeks 24 / 48 (CIC only).(Weeks 24 / 48 of treatment)
- At least 20% reduction of PS volume from baseline at Weeks 20 / 24.(Weeks 20 / 24 of treatment)
- Calorie reduction in the PN at Weeks 24.(Weeks 24 of treatment)
- Change from baseline on the Pittsburgh Sleep Quality Inventory (PSQI) at Weeks 24 / 48 (CIC only)(Weeks 24 / 48 of treatment)
- Change from baseline on the Patient Global Impression of Change (PGIC) at Weeks 24 / 48 (CIC only)(Weeks 24 / 48 of treatment.)
- Change from baseline on the Patient Global Impression of Treatment Satisfaction (PGI-TS) at week 24 and 48 (CIC only).(Weeks 24 / 48 of treatment)
- Change from baseline on the Patient Global Impression of Satisfaction with Parenteral Support (PGI-SPS) at Week 24 and 48 (CIC only).(Weeks 24 / 48 of treatment)
- Change from baseline on the Patient Global Impression of Parenteral Support Impact (PGI-PSI) at Week 24 and 48 (CIC only).(Weeks 24 / 48 of treatment)
- Absorption rate constant (ka) of apraglutide through population PK data analysis(Weeks 0 / 24 of treatment)
- Apparent clearance (CL/F) of apraglutide through population PK data analysis(Weeks 0 / 24 of treatment)
- Apparent volume of distribution (Vz/F) of apraglutide through population PK data analysis(Weeks 0 / 24 of treatment)
- At least 40% reduction of PS volume at Weeks 20 and 24 (Stoma only)(Weeks 20 / 24 of treatment)
- Trough plasma concentrations (Ctrough) at every other visit during the prolonged dosing period (CIC only)(Weeks 24 / 48 of treatment)
研究者
研究点 (68)
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