Adults 4 Months to 15, any sex, with Short Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy DataPrimary· Baseline, EOT (up to Week 24)
Absolute change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, milliliter per kilogram per day is abbreviated as mL/kg/day.
Group
Value
95% CI
Total Children (Aged: 1 to 15 Years)
-11.8
± 8.47
Infants (Corrected Gestational Age: 4 to < 12 Months)
-26.2
± 13.61
Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy DataPrimary· Baseline, EOT (up to Week 24)
Percent change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
Group
Value
95% CI
Total Children (Aged: 1 to 15 Years)
-27.7
± 31.79
Infants (Corrected Gestational Age: 4 to < 12 Months)
-26.7
± 15.14
Absolute Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy DataPrimary· Baseline, EOT (up to Week 24)
Absolute change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day).
Group
Value
95% CI
Total Children (Aged: 1 to 15 Years)
-7.2
± 8.70
Infants (Corrected Gestational Age: 4 to < 12 Months)
-13.8
± 3.17
Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy DataPrimary· Baseline, EOT (up to Week 24)
Percent change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
Group
Value
95% CI
Total Children (Aged: 1 to 15 Years)
-26.2
± 33.00
Infants (Corrected Gestational Age: 4 to < 12 Months)
-25.7
± 2.73
Absolute Change From Baseline in Plasma Citrulline at End of Treatment (EOT)Primary· Baseline, EOT (up to Week 24)
Absolute change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
Group
Value
95% CI
Total Children (Aged: 1 to 15 Years)
3.2
± 4.28
Percent Change From Baseline in Plasma Citrulline at End of Treatment (EOT)Primary· Baseline, EOT (up to Week 24)
Percent change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
Group
Value
95% CI
Total Children (Aged: 1 to 15 Years)
39.2
± 39.46
Absolute Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy DataPrimary· Baseline, EOT (up to Week 24)
Absolute change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
Group
Value
95% CI
Total Children (Aged: 1 to 15 Years)
1.0
± 7.14
Infants (Corrected Gestational Age: 4 to < 12 Months)
0.6
± 2.15
Percent Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy DataPrimary· Baseline, EOT (up to Week 24)
Percent change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
Group
Value
95% CI
Total Children (Aged: 1 to 15 Years)
53.1
± 111.01
Infants (Corrected Gestational Age: 4 to < 12 Months)
-23.2
± 36.89
Absolute Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy DataPrimary· Baseline, EOT (up to Week 24)
Absolute change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
Group
Value
95% CI
Total Children (Aged: 1 to 15 Years)
0.8
± 5.60
Infants (Corrected Gestational Age: 4 to < 12 Months)
0.3
± 1.03
Percent Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy DataPrimary· Baseline, EOT (up to Week 24)
Percent change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
Group
Value
95% CI
Total Children (Aged: 1 to 15 Years)
56.8
± 117.88
Infants (Corrected Gestational Age: 4 to < 12 Months)
-24.2
± 38.06
Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 24Primary· Week 24
Number of participants who achieved at least 20% reduction in PS volume at Week 24 was reported.
Group
Value
95% CI
Total Children (Aged: 1 to 15 Years)
4
Infants (Corrected Gestational Age: 4 to < 12 Months)
1
Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at End of Treatment (EOT)Primary· EOT (up to Week 24)
Number of participants who achieved at least 20% reduction in PS volume at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period.
Group
Value
95% CI
Total Children (Aged: 1 to 15 Years)
4
Infants (Corrected Gestational Age: 4 to < 12 Months)
1
Adverse events — posted to ClinicalTrials.gov
Time frame: From start of study drug administration up to end of the study (up to Week 28).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Total Children (Aged: 1 - 15 Years)
Serious: 6/8 (75%)
Deaths: 0/8
Infants (Corrected Gestational Age: 4 to < 12 Months)
The purpose of this study is to determine if an investigational treatment (teduglutide) is safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who are dependent on parenteral support. This study will also evaluate how teduglutide moves through the body (pharmacokinetics) and how it affects the body (pharmacodynamics).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07197944 — Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
· Phase 3
· recruiting
NCT05535361 — A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in A
· NA
· recruiting
NCT06973304 — A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome
· Phase 3
· recruiting
NCT06326645 — Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome
· EARLY_PHASE1
· recruiting
NCT06771505 — SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared With a Validated Quality of Life Question
· recruiting
Other Shire trials
Trials by the same sponsor.
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· Phase 4
· recruiting
NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism
· Phase 3
· withdrawn
NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease
· Phase 3
· terminated
NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India
· completed
NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study
· Phase 4
· withdrawn
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 2 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02980666.