Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07319832

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Short Bowel Syndrome (SBS) Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Short Bowel Syndrome

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou Women And Children's Medical Center, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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).
  • 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.

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: At Week 24

    Number of participants who are able to completely wean off PS support at Week 24 will be reported.

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

    Time frame: Baseline up to Week 24

    Absolute change from baseline in PN/IV support volume will be reported.

  3. Percent Change From Baseline in PN/IV Support Volume

    Time frame: Baseline up to Week 24

    Percent change from baseline in PN/IV support volume will be reported.

  4. Absolute Change From Baseline in PN/IV Support Calories

    Time frame: Baseline up to Week 24

    Absolute change from baseline in PN/IV support calories will be reported.

  5. Percent Change From Baseline in PN/IV Support Calories

    Time frame: Baseline up to Week 24

    Percent change from baseline in PN/IV support calories will be reported.

  6. Absolute Change From Baseline in Plasma Citrulline

    Time frame: Baseline, Week 24

    Absolute change from baseline in plasma citrulline will be reported.

  7. Percent Change From Baseline in Plasma Citrulline

    Time frame: Baseline, Week 24

    Percent change from baseline in plasma citrulline will be reported.

  8. Absolute Change From Baseline in Enteral Nutrition (EN) Support Volume

    Time frame: Baseline up to Week 24

    Absolute change from baseline in EN support volume will be reported.

  9. Percent Change From Baseline in EN Support Volume

    Time frame: Baseline up to Week 24

    Percent change from baseline in EN support volume will be reported.

  10. Absolute Change From Baseline in EN Support Calories

    Time frame: Baseline up to Week 24

    Absolute change from baseline in EN support calories will be reported.

  11. Percent Change From Baseline in EN Support Calories

    Time frame: Baseline up to Week 24

    Percent change from baseline in EN support calories will be reported.

  12. Change From Baseline in Hours per day of PN/IV Support

    Time frame: Baseline up to Week 24

    Change from baseline in hours per day of PN/IV support will be reported.

  13. Change From Baseline in Days per Week of PN/IV Support

    Time frame: Baseline up to Week 24

    Change from baseline in days per week of PN/IV support will be reported.

  14. Percentage of Participants with at Least a 20% Reduction From Baseline in PN/IV Volume

    Time frame: Baseline up to Week 24

    Percentage of participants with at least a 20% reduction from baseline in PN/IV volume will be reported.

  15. Change in Body Weight

    Time frame: Baseline up to Week 24

    Change in body weight will be reported.

  16. Change in Height

    Time frame: Baseline up to Week 24

    Change in height will be reported.

  17. Change in Head Circumference

    Time frame: Baseline up to Week 24

    Head circumference will be measured in participants 36 months of age and younger.

  18. Change in Height Z-score

    Time frame: Baseline up to Week 24

    Height is measured using Z-score. Z score is calculated as ([observed value/M]^L-1)/S*L, where observed value is the child's height. The L, M, and S values vary according to the child's sex and age.

  19. Change in Weight Z-score

    Time frame: Baseline up to Week 24

    Weight is measured using Z-score. Z score is calculated as ([observed value/M]^L-1)/S*L, where observed value is the child's weight. The L, M, and S values vary according to the child's sex and age.

  20. Change in Body Mass Index (BMI)

    Time frame: Baseline up to Week 24

    BMI is a simple measure that uses a participant's weight and height to estimate whether they are underweight, normal weight, overweight, or obese. It is calculated as weight in kilograms (kg) divided by height in meters squared (kg/m^2). Change in BMI will be reported.

  21. Change in BMI Z-score

    Time frame: Baseline up to Week 24

    BMI is measured using Z-score. Z score is calculated as ([observed value/M]^L-1)/S*L, where observed value is the child's BMI. The L, M, and S values vary according to the child's sex and age.

  22. Number of Participants with Adverse Events (AEs). Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

    Time frame: Up to 50 weeks

    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. An AE does not necessarily have a causal relationship withthis treatment. An AE can therefore be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product (investigational or marketed), whether or not considered related to treatment with the medicinal product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the product or program.

  23. Number of Participants with Clinically Significant Change in Vital Sign Values

    Time frame: Up to 24 weeks

    Vital signs will include measurement of temperature, heart rate, blood pressure and respiratory rate. Any clinically significant change in vital signs will be determined at the investigator's discretion.

  24. Body Weight in Participants Dependent on PS

    Time frame: Baseline up to Week 24

    Body weight in kg will be collected and reported.

  25. Head Circumference in Participants Dependent on PS

    Time frame: Baseline up to Week 24

    Head circumference in participants 36 months of age and younger will be collected and reported.

  26. Height in Participants Dependent on PS

    Time frame: Baseline up to Week 24

    Height in centimeters (cm) will be collected and reported.

  27. Trends on Growth Chart

    Time frame: Baseline up to Week 24

    Trends on growth chart will be collected and reported.

  28. Urine Output Determined up to Week 24

    Time frame: Baseline up to Week 24

    Collected and calculated values of urine output will be recorded over a 48-hour period of PN/IV and EN stability before every clinic visit and within 1 week of implementing a change in the PN/IV prescription.

  29. Fecal Output Measured by Volume

    Time frame: Baseline up to Week 24

    Collected and calculated values of fecal output should be recorded over a 48-hour period of PN/IV and EN stability before every clinic visit and within 1 week of implementing a change in the PN/IV prescription.

  30. Fecal Output Measured by Number of Bowel Movements per Day

    Time frame: Baseline up to Week 24

    Fecal output should be recorded over a 48-hour period of PN/IV and EN stability before every clinic visit and within 1 week of implementing a change in the PN/IV prescription.

  31. Number of Participants with Gastrointestinal-specific Testing

    Time frame: Baseline up to Week 24

    Gastrointestinal-specific testing will include colonoscopy or sigmoidoscopy or upper gastrointestinal (GI) endoscopy, abdominal ultrasound, fecal occult blood testing (FOBT), upper gastrointestinal series small bowel follow-through (UGI SBFT).

  32. Number of Participants With Clinically Significant Changes in Physical Examinations

    Time frame: Up to 24 weeks

    Physical examination will include assessing the participants physical status. (general surface, skin, head and neck, chest [heart, lungs, breasts], abdomen [gastrointestinal, liver and gallbladder], back, urinary system, limbs, nervous system, lymph nodes, etc.). Any clinically significant change in physical examination will be determined at the investigator's discretion.

  33. Number of Participants With Clinically Significant Changes in Laboratory Values

    Time frame: Up to 24 weeks

    Laboratory parameters will include hematology, chemistry and urinalysis. Any clinically significant change in laboratory values will be determined at the investigator's discretion.

  34. Number of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Parameters

    Time frame: Up to 24 weeks

    The 12-lead ECG will be evaluated. Any clinically significant change in ECG assessment will be determined at the investigator's discretion.

Study contacts

Contact information is provided by the study sponsor or research team.

Takeda Contact

CONTACT

[email protected]

+1-877-825-3327

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 6, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.