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

NCT07319832 | Recruiting

• 1 other identifier: TAK-633-5002
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Short Bowel Syndrome (SBS)

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieve at Least a 20% Reduction from Baseline in Weekly Parenteral Support (PS) Volume at Week 24

  Percentage of participants who achieve at least a 20 percent (%) reduction from baseline in weekly PS volume at Week 24 will be reported.

  At Week 24

Secondary Outcomes (34)

• Number of Participants Able to Completely Wean off PS Support at Week 24

  At Week 24

• Absolute Change from Baseline in PN/Intravenous (IV) Support Volume

  Baseline up to Week 24

• Percent Change From Baseline in PN/IV Support Volume

  Baseline up to Week 24

• Absolute Change From Baseline in PN/IV Support Calories

  Baseline up to Week 24

• Percent Change From Baseline in PN/IV Support Calories

  Baseline up to Week 24

Study Arms (3)

Retrospective Group

Participants who completed the 24-week teduglutide treatment period before enrollment will have their clinical data collected retrospectively from their medical records.

Other: No Intervention

Mixed Group

Participants who initiated treatment before the study start date but have not completed the 24-week teduglutide treatment period at the time of enrollment will have their clinical data collected retrospectively before enrollment and prospectively after enrollment.

Other: No Intervention

Prospective Group

Participants who will initiate the teduglutide treatment period after enrollment will have their clinical data collected prospectively for 48 weeks.

Other: No Intervention

Interventions

No Intervention OTHER

No Intervention

Mixed Group; Prospective Group; Retrospective Group

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of Chinese pediatric participants with SBS who are dependent on PS.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Total Bilirubin Level (TBL) \>= 2 × upper limit of normal (ULN)
• Aspartate Aminotransferase (AST) \>=7 × ULN
• Alanine Aminotransferase (ALT) \>=7 × ULN
• For Participants with Gilbert's disease:
• 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).

Sponsors & Collaborators

• Takeda: lead

Study Sites (4)

Guangzhou Women And Children's Medical Center

Guangzhou, Guangdong, 510040, China

NOT YET RECRUITING

Shanghai Children's Hospital

Shanghai, Shanghai Municipality, 200062, China

NOT YET RECRUITING

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Children's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310006, China

NOT YET RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 6, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CN (4)