Actively Recruiting
A Multicenter Observational Study to Evaluate the Safety and Effectiveness of Teduglutide in Treating Short Bowel Syndrome in Chinese Children and Teenagers Aged 1 to 17 Years
Led by Takeda · Updated on 2026-03-13
12
Participants Needed
4
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Short Bowel Syndrome (SBS) is a rare condition where a large part of the intestine is missing or has been removed, causing difficulty in absorbing enough food, water, and nutrients. This study focuses on children and teenagers with SBS who depend on parenteral support (PS) for more than 42 days to stay healthy. Researchers aim to learn how well teduglutide works to reduce the need for PS and to assess its safety in this group. The study includes three groups of participants: those who completed a 24-week teduglutide treatment before joining the study, those who started treatment before the study but have not finished 24 weeks, and those who will begin treatment after enrolling. Data will be collected retrospectively for earlier treatments and prospectively for ongoing or future treatments, covering up to 48 weeks for new starters. No intervention is administered by the study itself as it is observational. Participants will have their medical records reviewed, and new data collected during the study period. Researchers will measure changes in weekly PS volume, growth parameters, nutrition support, and safety through lab tests, vital signs, and adverse events. The main outcome is the percentage of participants achieving at least a 20% reduction in weekly PS volume at 24 weeks. The study will continue until September 2027, with ongoing monitoring of health and treatment responses.
CONDITIONS
Brief Title
A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 1 through 17 years at Day 1
- Documented diagnosis of Short Bowel Syndrome (SBS)
- Received or plan to receive teduglutide treatment for at least 24 weeks
- Stable parenteral nutrition/intravenous support with minimal changes (10% or less) for at least 3 months before Day 1
- Informed consent obtained from participants aged 8 to 17 and their guardians; guardians provide consent for those under 8, unless waived by ethics committee
You will not qualify if you...
- Unable to advance oral or tube feeding regimens
- Bowel lengthening surgery (e.g., STEP) within 3 months before baseline
- Untreated significant intestinal obstruction causing feeding intolerance or inability to reduce parenteral support
- Evidence of significant obstruction on upper GI series within 6 months before baseline
- Use of octreotide or DPP-4 inhibitors within 3 months before baseline
- Active, severe, or unstable liver impairment indicated by specific lab test thresholds
- Active or unstable significant kidney dysfunction with eGFR below 50 mL/min/1.73m²
- Known allergy to teduglutide or its ingredients
- Body weight less than 10 kg at baseline
- Previous use of teduglutide or Glucagon-like Peptide-2 (GLP-2)
- Use of GLP-1 analog or human growth hormone within 3 months before baseline
- Any other condition that poses undue risk or interferes with study completion or results analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 48 weeks depending on the group
Participants' clinical data related to teduglutide treatment and Short Bowel Syndrome are collected and observed.
Assessment visits depending on retrospective, mixed, or prospective group assignment
Trial Site Locations
Total: 4 locations
1
Guangzhou Women And Children's Medical Center
Guangzhou, Guangdong, China, 510040
Not Yet Recruiting
2
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China, 200062
Not Yet Recruiting
3
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092
Actively Recruiting
4
Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006
Not Yet Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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