JPRN-jRCT2080223972已完成3 期
An Open-Label, Extension Study of Teduglutide in Japanese Subjects With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 11
研究概览
简要总结
ong-term treatment with teduglutide produced sustained clinically meaningful reductions in PS requirements.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 ot applicable(—)
- 性别
- All
入选标准
- •Subjects who met all of the following criteria were eligible for inclusion in the study:
- •1.Ability to voluntarily provide written, signed, and informed consent to participate in the study.
- •2.Completion of the SHP633-306 study or participation in TED-C14-004 (NCT02340819) Stage 3 or Stage 4.
- •3.Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol.
- •4.An understanding, ability, and willingness to fully comply with study procedures and restrictions.
排除标准
- •There are no exclusion criteria for this study.
研究者
相似试验
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An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004Short Bowel SyndromeNCT03596164Takeda11
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A Long Term, Open Label Study with Teduglutide for Subjects with Parenteral Nutrition Dependent Short Bowel SyndromeMedDRA version: 14.1Level: PTClassification code 10049416Term: Short-bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disordersShort Bowel SyndromeEUCTR2009-011679-65-DEPS Pharmaceuticals, Inc.84
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