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A 24-Week Double-blind, Safety, Efficacy, and Pharmacodynamic Study Investigating Two Doses of Teduglutide in Pediatric Subjects Through 17 Years of Age With Short Bowel Syndrome Who Are Dependent on Parenteral Support

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DataCite Commons2024-12-02 更新2026-05-07 收录
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资源简介:
Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose of this study is to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on parenteral support. Subjects may choose whether to receive the study drug or to participate in a standard-of-care arm. All participants who complete the study may be eligible to receive the study drug in a long-term extension study.

替度鲁肽(Teduglutide)已获批用于治疗成人短肠综合征(SBS)。本研究旨在评估替度鲁肽对17岁及以下、依赖肠外支持的短肠综合征儿童患者的安全性与有效性。受试者可自主选择接受研究药物,或加入标准治疗组。所有完成本研究的参与者,均有资格参与后续长期扩展研究并接受研究药物治疗。
提供机构:
Vivli
创建时间:
2021-04-07
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