EUCTR2009-011679-65-DK进行中（未招募）不适用
A Long Term, Open Label Study with Teduglutide for Subjects with Parenteral Nutrition Dependent Short Bowel Syndrome
PS Pharmaceuticals, Inc.0 个研究点目标入组 84 人开始时间: 2010年3月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
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
- •Subjects who meet all of the following criteria can be enrolled in this study:
- •1. Completion of 24-weeks of dosing in Study CL0600-020 or based on investigator and sponsor decision if the subject was required to stop dosing prematurely due to a non-drug related adverse experience or successful completion of stage I (optimization/stabilization) in Study CL0600-020 (ie., qualification for randomization) after approximately 86 subjects have been randomized.
- •2. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study CL0600-021 are performed.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria do not apply as only those subjects who have participated in Study CL0600-020 and do not meet the events necessitating withdrawal from the study as listed in Section 4.4.2 of this protocol are eligible.
研究者
相似试验
进行中（未招募）
不适用
A Long Term, Open Label Study with Teduglutide for Subjects with Parenteral Nutrition Dependent Short Bowel Syndrome Estudio a largo plazo y en régimen abierto de teduglutida en sujetos con síndrome del intestino corto dependientes de nutrición parenteralShort Bowel SyndromeSindrome de Intestino CortoMedDRA version: 12.0Level: LLTClassification code 10049416Term: <Manually entered code. Term in E.1.1>EUCTR2009-011679-65-ESPS Pharmaceuticals, Inc.86
进行中（未招募）
不适用
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
进行中（未招募）
1 期
A Long Term, Open Label Study with Teduglutide for Subjects with Parenteral Nutrition Dependent Short Bowel SyndromeMedDRA version: 14.1 Level: PT Classification code 10049416 Term: Short-bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersShort Bowel SyndromeEUCTR2009-011679-65-GBPS Pharmaceuticals84
进行中（未招募）
1 期
A Long Term, Open Label Study with Teduglutide for Subjects with Parenteral Nutrition Dependent Short Bowel SyndromeMedDRA version: 12.0Level: LLTClassification code 10049416Term: <Manually entered code. Term in E.1.1>Short Bowel SyndromeEUCTR2009-011679-65-FRPS Pharmaceuticals, Inc.84
进行中（未招募）
不适用
A Long Term, Open Labeled Study with Teduglutide for Subjects with Parenteral Nutrition-Dependent Short Bowel Syndrome who completed Study Cl0600020 - Cl0600021MedDRA version: 9.1Level: LLTClassification code 10049416Short Bowel SyndromeEUCTR2009-011679-65-ITPS PHARMACEUTICALS66