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Trial · Interventional

Active, not recruitingPhase 3Registry data

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
13 participants (actual)
Sponsor
Takeda · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
26 Jun 2025
Primary completion
10 Feb 2027 (estimated)
Completion
28 Jul 2027 (estimated)
First posted
15 May 2025
Last update posted
8 Sept 2026
Conditions
Short Bowel Syndrome

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 3

    A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

    NCT06973304

    26 Jun 2025 to est. 28 Jul 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main aim of the study is to assess how well teduglutide works over 24 weeks in Chinese adult participants with short bowel syndrome (SBS) who need parenteral support and to see how much it can reduce the amount of parenteral support and understand how the body absorbs, processes, and gets rid of teduglutide. Participants will receive a daily injection of teduglutide under the skin for 24 weeks. Safety of teduglutide will be checked for 24 weeks after treatment. Participants will be in the study for about 65 weeks.

Interventions

  • TeduglutideDrug

Arms1

  • Experimental

    Teduglutide 0.05 milligram per kilogram (mg/kg)

    Participants will receive teduglutide 0.05 mg/kg subcutaneous (SC) injection, once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm for 24 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Participants Who Achieved At Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20 and Maintained Through Week 24

    Time frame · Up to Week 24

Secondary outcomes(20)
  1. Absolute Change From Baseline in Weekly PS Volume up to Week 24

    Time frame · Baseline up to Week 24

  2. Percent Change From Baseline in Weekly PS Volume up to Week 24

    Time frame · Baseline up to Week 24

  3. Absolute Change From Baseline in Days Per Week of PS up to Week 24

    Time frame · Baseline up to Week 24

  4. Percent Change From Baseline in Days Per Week of PS up to Week 24

    Time frame · Baseline up to Week 24

  5. Number of Participants Who Achieved At Least 20% Reduction From Baseline in Weekly PS Volume at each visit

    Time frame · Up to Week 24

  6. Number of Participants With At Least a 20% Reduction From Baseline in Weekly PS at Week 20 and Maintained Through Week 24

    Time frame · Baseline, Week 20 and Week 24

  7. Number of Participants With At Least a 2-liter Reduction From Baseline in Weekly PS at Week 20 and Maintained Through Week 24

    Time frame · Baseline, Week 20 and Week 24

  8. Number of Participants who are able to Completely Wean off of PS support at Week 24

    Time frame · At Week 24

  9. Time From First Dose to Time of Completely Weaning off of PS Support

    Time frame · Up to Week 24

  10. AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity for Teduglutide

    Time frame · Predose, 1, 2, 4, 6, 8, and 10 hours post-dose

  11. AUC0-last: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Teduglutide

    Time frame · Predose, 1, 2, 4, 6, 8, and 10 hours post-dose

  12. Cmax: Maximum Observed Plasma Concentration for Teduglutide

    Time frame · Predose, 1, 2, 4, 6, 8, and 10 hours post-dose

  13. Tmax: Time to Reach the Cmax for Teduglutide

    Time frame · Predose, 1, 2, 4, 6, 8, and 10 hours post-dose

  14. T1/2: Terminal Phase Half-life for Teduglutide

    Time frame · Predose, 1, 2, 4, 6, 8, and 10 hours post-dose

  15. CL/F: Apparent Clearance for Teduglutide

    Time frame · Predose, 1, 2, 4, 6, 8, and 10 hours post-dose

  16. V/F: Apparent Volume of Distribution During the Terminal Elimination Phase for Teduglutide

    Time frame · Predose, 1, 2, 4, 6, 8, and 10 hours post-dose

  17. Plasma Concentrations of Teduglutide

    Time frame · At Week 4 and Week 24

  18. Number of Participants With Positive Antidrug Antibodies (Neutralizing and Non-neutralizing)

    Time frame · Baseline, Week 4, and Week 24

  19. Number of Participants Who Experienced At Least One Treatment-emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI)

    Time frame · From first dose of study drug up to follow-up (Week 48)

  20. Change From Baseline in 48-hour Urine Output

    Time frame · Baseline up to 48 hours

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Males or females 18 years of age or older at the time of signing the informed consent. 2. Intestinal failure due to SBS as a consequence of major intestinal resection (example, due to injury, volvulus, vascular disease, cancer, Crohn's disease). 3. Has undergone intestinal resection resulting in at least 12 continuous months of PS dependency prior to signing the informed consent. 4. Requires PS at least 3 times per week or at least 4 liters per week during the 2 weeks prior to baseline to meet caloric, fluid, or electrolyte needs due to ongoing malabsorption. 5. Has a stable PS requirement for at least 4 consecutive weeks immediately prior to the start of teduglutide treatment. Stability is defined as follows: 1. Actual PS usage is similar to prescribed PS. 2. Baseline (Visit 2) 48-hour intake (I)/output (O) volumes should fall within +-25% of the respective 48-hour I/O volumes at the last optimization visit. 3. The 48-hour urine output volume must not be less than 2 liters and should not exceed 4 liters at the last optimization visit, the stabilization visit, and the baseline visit. 6. Participants with a history of Crohn's disease must be in endoscopic remission for at least 12 weeks prior to the baseline visit. Exclusion Criteria: 1. Pregnant or lactating female. 2. Participation in a clinical study using an experimental drug within 30 days or 5 half-lives, whichever is longer, prior to screening, or concurrent participation in any other clinical study. 3. Use of glucagon-like peptide (GLP)-2 or human growth hormone or analogs of these hormones within the past 6 months prior to the baseline visit. 4. Use of octreotide, GLP-1 analogs, or dipeptidyl peptidase-4 inhibitors within 30 days prior to the baseline visit. 5. Previous use of teduglutide. 6. Active inflammatory bowel disease (IBD) or any participant with IBD requiring immunosuppressant therapy (example, azathioprine,anti-tumor necrosis factor \[anti-TNF\]) drugs) that had been introduced or changed within the past 6 months prior to the baseline visit. 7. Intestinal malabsorption due to a genetic condition, such as cystic fibrosis, microvillus inclusion disease, familial adenomatous polyposis. 8. Chronic intestinal pseudo-obstruction or severe dysmotility. 9. Clinically significant intestinal stenosis or obstruction, or evidence of such on upper gastrointestinal (UGI)/small bowel follow-through (SBFT), within the past 6 months prior to the baseline visit. 10. Major gastrointestinal (GI) surgical intervention, including significant intestinal resection, within the past 3 months (insertion of feeding tube, anastomotic ulcer repair, minor intestinal resections less than or equal to \[\<=\] 10 centimeter \[cm\], or endoscopic procedure is allowed) prior to the baseline visit. 11. Unstable cardiac disease, (example, congestive heart failure, cyanotic disease, or congenital heart disease). 12. Moderate or severe renal impairment, defined as creatinine clearance less than 50 milliliters per minute (mL/min). 13. Currently diagnosed with cancer or a history of any cancer except surgically cured skin cancer within the past 5 years. 14. Severe hepatobiliary disease including any of the following: 1. Total bilirubin level at least 2 times the upper limit of normal (ULN), except for increased indirect (unconjugated) bilirubin in a patient with Gilbert's syndrome. 2. AST at least 5\*ULN. 3. ALT at least 5\*ULN 15. Active clinically significant pancreatic disease, including clinical signs of pancreatitis associated with elevations in serum amylase or lipase at least 2\*ULN. 16. More than 4 SBS-related or PS-related hospital admissions (example, central line-associated bloodstream infection, bowel obstruction, severe fluid/electrolyte disturbances) within the past 12 months prior to the baseline visit. 17. Unscheduled hospitalization within 30 days prior to screening. 18. Non-herpetic viral diseases: 1. Presence of hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV RNA (ribonucleic acid) (nucleic acid test or polymerase chain reaction). 2. Presence of (Hepatitis B Surface Antigen Positive \[HBsAg+\]). For participants who are negative for HBsAg but are positive for either surface antibodies and/or core antibodies, hepatitis B virus (HBV) deoxyribonucleic acid (DNA) polymerase chain reaction will be performed; if any test result meets or exceeds detection sensitivity, the subject will be excluded. 3. Positive results for human immunodeficiency virus (HIV) by serology, regardless of viral load. 19. Any condition, disease, illness, or circumstance that in the investigator's opinion puts the participant at any undue risk, prevents completion of the study, or interferes with analysis of the study results. Example of potential disease state/illnesses that may be excluded are listed in the protocol.

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