EUCTR2020-001202-32-NO进行中（未招募）1 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) - Efficacy and Safety of apraglutide in SBS-IF
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- VectivBio AG
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent for this trial prior to any trial specific assessment.
- •2. Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC).
- •3. Subject must require PS at least 3 days per week and be considered stable.
- •4. No planned restorative surgery or major intestinal surgery (more than 10% intestinal resection or surgery that changes anatomy group i.e. stoma or CIC), in the trial period.
- •5. Age =18 years at Screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 52
排除标准
- •11.Pregnancy and/or lactation.
- •2.Major abdominal surgery in the last 6 months prior to screening visit.
- •3.History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within =5 years, except for adequately treated basal cell skin cancer.
- •4.Active inflammatory bowel diseases (IBD) or underlying condition that requires new drug treatment or regimen changes in the previous 3 months.
- •5.Evidence of decompensated heart failure.
- •6.Evidence of severe renal or hepatic impairment.
- •7.Any treatment of greater than 2 weeks of growth factors such as growth hormone (GH), native GLP-2, GLP-1, short acting GLP-2 analogues (e.g., teduglutide) or GLP-1 analogues in the previous 3 months before randomization or treatment with longer acting experimental GLP-2 analogues should be discussed with the Investigator.
研究者
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