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A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
Sponsor: Takeda
Summary
Short Bowel Syndrome (SBS) is a rare condition that happens when a large part of the bowel (also called intestine) is missing or has been removed because of illness or surgery. In children, SBS means that the intestine cannot absorb enough food, water and important part of food the body needs (called nutrients) because a big part of it has been removed, bypassed or did not develop normally at birth and the children need support through a vein (parenteral support or PS) for more than 42 days to stay healthy and keep their energy. SBS in children is defined mainly by how well the intestine works and how long the children need this support, not just by how long the intestine is. The main aim of the study is to learn how well the teduglutide works in children and teenagers with SBS and who need PS. Another aim is to find out how well teduglutide works for participants to lower the amount of PS needed. Also, the study wants to learn more about how safe teduglutide is in children and teenagers with SBS who need PS. The study will review data already existing in the medical records of participants as well as collect new data during the study.
Official title: A Multicenter, Retrospective and Prospective, Observational Study to Evaluate the Efficacy and Safety of Subcutaneous Teduglutide in the Treatment of Short Bowel Syndrome (SBS) in Parenteral Nutrition (PN) Dependent Chinese Pediatric Subjects (≥1 Through 17 Years Old)
Key Details
Gender
All
Age Range
1 Year - 17 Years
Study Type
OBSERVATIONAL
Enrollment
12
Start Date
2026-03-05
Completion Date
2027-09-30
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
No Intervention
No Intervention
Locations (4)
Guangzhou Women And Children's Medical Center
Guangzhou, Guangdong, China
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China