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RECRUITING
NCT07319832

A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome

Sponsor: Takeda

View on ClinicalTrials.gov

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

Interventions

OTHER

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