EUCTR2017-001405-32-FR进行中（未招募）1 期
A Monocentric Single-arm study to characterize the long-term safety, efficacy, and pharmacodynamic of GLP-2 analog (Revestive®) in the management of short bowel syndrome pediatric patients on home-parenteral nutrition (HPN)
Institut des Maladies Génétiques - Imagine0 个研究点目标入组 25 人开始时间: 2017年9月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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
- •- Being aged from 2 to 18 years old included ;
- •- Presenting less than 80 cm of residual small intestine with or without the terminal ileum, ileocecal valve and right colon or left with less than 120 cm in case of SBS caused by Hirschsprung disease;
- •- Being stable on PN support (inability to significantly reduce PN intake for the last six months before inclusion) ;
- •- Being dependent on PN for at least 2 year and enterally fed (oral or tube feeding) ;
- •- Having a normal colonoscopy in the 12 month before screening (for children with a SBS type 2 or 3 older than 12 years) ;
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Having a major gastrointestinal surgical intervention like serial transverse enteroplasty or any other bowel lengthening procedure performed within 6 months of screening ;
- •- Having a clinically significant untreated intestinal obstruction or active stenosis ;
- •- Having an unstable absorption due to cystic fibrosis or known DNA abnormalities ;
- •- Presenting a radiographic or manometric evidence of pseudo-obstruction or severe known dysmotility syndrome, including persistent, severe gastroschisis-related motility disorders ;
- •- Having an unstable cardiac disease, congenital heart disease or cyanotic disease, with the exception of patients who had undergone ventricular or atrial septal defect repair ;
- •- Having an history of cancer or clinically significant lymphoproliferative disease; excepted resected cutaneous basal or squamous cell carcinoma, or in situ non-aggressive and surgically resected cancer ;
- •- Having participated in a clinical study using an experimental drug within 1 month or an experimental antibody treatment within 3 months prior to screening, or concurrent participation in any clinical study using an experimental drug that would affect the safety of teduglutide ;
- •- Having already used native GLP-2 and glucagon-like peptide-1 analog or human growth hormone within 3 months prior to screening ;
- •- Having already used oral or IV glutamine, octreotide, or dipeptidyl peptidase IV (DPP-IV) inhibitors within 3 months prior to screening ;
- •- Having an active Crohn’s disease which has been treated with biological therapy within the 6 months prior to screening ;
- •- Having an intestinal polyposis;
- •- Being, for female patient, both lactating and breast-feeding or having a positive pregnancy test during the screening period;
- •- Refusing the follow the protocol requirements in terms of birth control ;
- •- Being unable to follow the study procedures for any reason: psychological, geographical…
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