Study · Non-randomized trial · n = 78 · 2024

5 results

Long-term teduglutide associated with improved response in pediatric short bowel syndrome-associated intestinal failure.

Wales PW, Hill S, Robinson I, Raphael BP, Matthews C, Cohran V, Carter B, Venick R, Kocoshis S

Journal of pediatric gastroenterology and nutrition14 Jun 2024Cited by 15 (Europe PMC)

PMID38873891DOI10.1002/jpn3.12276PepBankPUB-38873891

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanNon-randomized trialSafety outcome
In children with SBS-IF, most TEAEs were moderate or severe in intensity in the any-teduglutide group and in the seven patients who did not receive teduglutide in either the parent or LTE studies.
In plain wordsIn children with SBS-IF, most adverse events were moderate or severe both in patients who received teduglutide and in the seven who did not.
Peptide
Teduglutide
Outcome
Not applicableTEAE intensity
Study
n = 78
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Source sentences
Summary
Most TEAEs were moderate or severe in intensity in both groups.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a pooled, post hoc analysis of two open-label, long-term extension (LTE) studies (NCT02949362 and NCT02954458) in children with SBS-IF.
Summary · context
Overall, 85 patients were analyzed; 78 patients received teduglutide in the parent and/or LTE studies (any teduglutide [TED] group), while seven patients did not receive teduglutide in either the parent or LTE studies.
Report a problemFND-3887389101
02HumanNon-randomized trialEfficacy outcome
By week 96, 82.1% of teduglutide-treated children achieved at least a 20% reduction in PN/IV volume from baseline.
In plain wordsBy week 96, 82.1% of children receiving teduglutide reduced intravenous support volume by at least 20%.
Peptide
Teduglutide
Outcome
DecreaseClinical response by week 96
Study
n = 78
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
Dose not stated
Measurements
Response
82.1%
reported result
Source sentences
Summary
By week 96, 82.1% of patients from the any TED group achieved a clinical response, with a mean fluid decrease of 30.1 mL/kg/day and an energy decrease of 21.6 kcal/kg/day.
3 context sentences(design, population, supporting numbers)
Summary · context
Endpoints included treatment-emergent adverse events (TEAEs) and clinical response (≥20% reduction in PN/IV volume from baseline).
Summary · context
This was a pooled, post hoc analysis of two open-label, long-term extension (LTE) studies (NCT02949362 and NCT02954458) in children with SBS-IF.
Summary · context
Overall, 85 patients were analyzed; 78 patients received teduglutide in the parent and/or LTE studies (any teduglutide [TED] group), while seven patients did not receive teduglutide in either the parent or LTE studies.
Report a problemFND-3887389102
03HumanNon-randomized trialEfficacy outcome
By week 96, teduglutide-treated children had a mean PN/IV fluid requirement decrease of 30.1 mL/kg/day.
In plain wordsBy week 96, children receiving teduglutide needed 30.1 mL/kg/day less intravenous fluid support on average.
Peptide
Teduglutide
Outcome
DecreaseFluid requirement
Study
n = 78
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
Dose not stated
Measurements
Fluid decrease
30.1 mL/kg/day
reported result
Source sentences
Summary
By week 96, 82.1% of patients from the any TED group achieved a clinical response, with a mean fluid decrease of 30.1 mL/kg/day and an energy decrease of 21.6 kcal/kg/day.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a pooled, post hoc analysis of two open-label, long-term extension (LTE) studies (NCT02949362 and NCT02954458) in children with SBS-IF.
Summary · context
Overall, 85 patients were analyzed; 78 patients received teduglutide in the parent and/or LTE studies (any teduglutide [TED] group), while seven patients did not receive teduglutide in either the parent or LTE studies.
Report a problemFND-3887389103
04HumanNon-randomized trialEfficacy outcome
By week 96, teduglutide-treated children had a mean PN/IV energy requirement decrease of 21.6 kcal/kg/day.
In plain wordsBy week 96, children receiving teduglutide needed 21.6 kcal/kg/day less intravenous energy support on average.
Peptide
Teduglutide
Outcome
DecreaseEnergy requirement
Study
n = 78
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
Dose not stated
Measurements
Energy decrease
21.6 kcal/kg/day
reported result
Source sentences
Summary
By week 96, 82.1% of patients from the any TED group achieved a clinical response, with a mean fluid decrease of 30.1 mL/kg/day and an energy decrease of 21.6 kcal/kg/day.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a pooled, post hoc analysis of two open-label, long-term extension (LTE) studies (NCT02949362 and NCT02954458) in children with SBS-IF.
Summary · context
Overall, 85 patients were analyzed; 78 patients received teduglutide in the parent and/or LTE studies (any teduglutide [TED] group), while seven patients did not receive teduglutide in either the parent or LTE studies.
Report a problemFND-3887389104
05HumanObservational studyEfficacy outcome
In pediatric SBS-IF, longer duration of teduglutide exposure was significantly associated with a reduction in mean PN/IV volume requirements.
In plain wordsIn children with SBS-IF, longer teduglutide exposure was linked to a larger drop in intravenous support needs.
Peptide
Teduglutide
Outcome
DecreaseTeduglutide exposure duration and PN/IV volume reduction
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
Colon-in-continuity, non-White race, older age at baseline, longer duration of teduglutide exposure, and increasing length of remaining small intestine were significantly associated with a reduction in mean PN/IV volume requirements.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a pooled, post hoc analysis of two open-label, long-term extension (LTE) studies (NCT02949362 and NCT02954458) in children with SBS-IF.
Summary · context
Overall, 85 patients were analyzed; 78 patients received teduglutide in the parent and/or LTE studies (any teduglutide [TED] group), while seven patients did not receive teduglutide in either the parent or LTE studies.
Report a problemFND-3887389105

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT02954458

Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)

Shiren = 619 Jan 2017 to 5 Nov 2020

Short Bowel Syndrome

Trial page ClinicalTrials.govUpdated 28 Mar 2025

CompletedPhase 3Results postedNCT02949362

Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study

Shiren = 299 Dec 2016 to 14 Jul 2020

Short Bowel Syndrome

Trial page ClinicalTrials.govUpdated 19 Mar 2025

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.