Teduglutide treatment for Chinese children and teenagers with short bowel syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows children and adolescents (1–17 years) with documented short bowel syndrome who are receiving or plan to receive teduglutide for at least 24 weeks. Investigators will record changes in parenteral support (PN/IV), growth and nutritional markers, and monitor safety events during routine care. Eligible participants typically have had stable PN/IV support for at least three months prior to enrollment, with allowance for brief interruptions that return to baseline. The study is being conducted at pediatric centers in Guangzhou and Shanghai and collects real-world treatment and safety data without assigning experimental interventions.

Why it matters

Who can join: the full rules

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

* Participants who are not expected to be able to advance oral or tube feeding regimens.
* Serial Transverse Enteroplasty (STEP) or any other bowel lengthening procedure performed within 3 months prior to baseline.
* Known clinically significant untreated intestinal obstruction contributing to feeding intolerance and inability to reduce PS.
* Evidence of clinically significant obstruction on upper GI series done within 6 months prior to baseline.
* Previous use of octreotide or Dipeptidyl peptidase-4 (DPP-4) inhibitors within 3 months prior to baseline.
* 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:

  1. Total Bilirubin Level (TBL) \>= 2 × upper limit of normal (ULN)
  2. Aspartate Aminotransferase (AST) \>=7 × ULN
  3. Alanine Aminotransferase (ALT) \>=7 × ULN

     For Participants with Gilbert's disease:
  4. Indirect (unconjugated) bilirubin \>=2 × ULN
* 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).
* Known hypersensitivity of the active substance or excipient of teduglutide.
* Body weight less than (\<) 10 kg at baseline.
* Previous use of teduglutide or native/synthetic Glucagon-like Peptide-2 (GLP-2).
* Previous use of GLP-1 analog or human growth hormone within 3 months prior to baseline.
* 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.

Where it's running

• Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• Guangzhou Women And Children's Medical Center
  Guangzhou, Guangdong, China Not yet recruiting
• Shanghai Children's Hospital
  Shanghai, Shanghai Municipality, China Not yet recruiting
• Children's Hospital Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Not yet recruiting

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Apraglutide vs placebo in adults with short bowel syndrome and intestinal failure

  This Phase 3 study tests whether weekly injections of apraglutide help adults with SBS-IF who rely on parenteral nutrition, compared with placebo, over 24 weeks.

  Recruiting Phase 3 VectivBio AG · Los Angeles, California and 93 other locations · NCT07742735

• How teduglutide affects intestinal organoids from children with short bowel syndrome

  This project will test whether teduglutide changes how lab-grown intestinal tissue from children with short bowel syndrome grows and absorbs nutrients to explain why some kids respond differently.

  Recruiting Meyer Children's Hospital IRCCS · Florence, Florence · NCT07400783

• RhGH injections for adults with short bowel syndrome on PN

  This study tests whether giving growth hormone injections helps adults with short bowel syndrome who rely on parenteral nutrition.

  Recruiting at 2 sites Phase 4 Changchun GeneScience Pharmaceutical Co., Ltd. · Xiamen, Fujian and 1 other locations · NCT07691125

• Resting energy tests in people with normal digestion vs. intestinal failure

  This study tests resting energy expenditure in adults with and without intestinal failure to help tailor nutrition needs.

  Recruiting Institute of Oncology Ljubljana · Ljubljana · NCT07714499

• FT1 for adults with short bowel syndrome: a safe, quick-study test

  This trial tests FT1 vs placebo in adults with short bowel syndrome to see if FT1 is safe and helps with their condition.

  Recruiting Phase 2 Chongqing Peg-Bio Biopharm Co., Ltd. · Nanjing, Jiangsu · NCT07704047

• Glepaglutide for adults with short bowel syndrome and intestinal failure

  This trial tests whether glepaglutide 10 mg given twice weekly can reduce the need for parenteral support in adults with short bowel syndrome and intestinal failure.

  Recruiting at 32 sites Phase 3 Zealand Pharma · Chicago, Illinois and 32 other locations · NCT07197944

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.