Status:
RECRUITING
A Study of Teduglutide in Chinese Children and Teenagers With Short Bowel Syndrome
Lead Sponsor:
Takeda
Conditions:
Short Bowel Syndrome (SBS)
Eligibility:
All Genders
1-17 years
Brief 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 ...
Eligibility Criteria
Inclusion criteria
- Children and adolescents greater than or equal to (>=)1 through 17 years of age at Day 1 (D1).
- Documented diagnosis of SBS.
- Received or plan to receive Teduglutide treatment for a minimum of 24 weeks.
- Stable PN/IV support, defined as inability to significantly reduce PN/IV support, usually associated with minimal or no advance in enteral feeds (i.e., 10% or less change in PN or advance in feeds) for at least 3 months prior to D1, as assessed by the investigator. Transient instability for events such as interruption of central access or treatment for sepsis is allowed if the PN/IV support returns to within 10% of baseline prior to the event.
- Informed consent obtained from the patient aged 8 to 17 years and their guardians, while informed consent from the guardians for participants under 8 years old, unless waived by the Institution's Ethics Committee.
Exclusion criteria
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Participants who are not expected to be able to advance oral or tube feeding regimens.
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Serial Transverse Enteroplasty (STEP) or any other bowel lengthening procedure performed within 3 months prior to baseline.
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Known clinically significant untreated intestinal obstruction contributing to feeding intolerance and inability to reduce PS.
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Evidence of clinically significant obstruction on upper GI series done within 6 months prior to baseline.
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Previous use of octreotide or Dipeptidyl peptidase-4 (DPP-4) inhibitors within 3 months prior to baseline.
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Signs of active, severe, or unstable clinically significant hepatic impairment during the screening or baseline period, indicative by any of the following laboratory test results:
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Total Bilirubin Level (TBL) >= 2 × upper limit of normal (ULN)
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Aspartate Aminotransferase (AST) >=7 × ULN
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Alanine Aminotransferase (ALT) >=7 × ULN
For Participants with Gilbert's disease:
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Indirect (unconjugated) bilirubin >=2 × ULN
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Signs of known continuous active or unstable, clinically significant renal dysfunction shown by results of an estimated glomerular filtration rate (eGFR) below 50 millilitres per minutes per 1.73 meter square (mL/min/1.73 m^2).
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Known hypersensitivity of the active substance or excipient of teduglutide.
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Body weight less than (<) 10 kg at baseline.
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Previous use of teduglutide or native/synthetic Glucagon-like Peptide-2 (GLP-2).
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Previous use of GLP-1 analog or human growth hormone within 3 months prior to baseline.
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Any condition, disease, illness, or circumstance that in the investigator's opinion puts the patient at any undue risk, prevents completion of the study, or interferes with analysis of the study results.
Key Trial Info
Start Date :
March 5 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07319832
Start Date
March 5 2026
End Date
September 30 2027
Last Update
March 13 2026
Active Locations (4)
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1
Guangzhou Women And Children's Medical Center
Guangzhou, Guangdong, China, 510040
2
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China, 200062
3
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092
4
Children's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310006