Evidence map›Paper›PMID 41454663›Full record

Trial reportPediatrics international : official journal of the Japan Pediatric Society

Teduglutide in pediatric patients under 10 kg with short bowel syndrome on parenteral support: An open-label study.

Kouji Masumoto, Mitsuru Muto, Takato Sasaki, Mitsuhiro Shikamura, Tomoko Tanaka, Sho Sakui, Masakazu Miyamoto, Hiroya Nakano, Taisuke Kondo, Satoshi Ieiri

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatrics international : official journal of the Japan Pediatric Society. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05027308 (A Phase 3, Open-label Safety Study of Teduglutide in Japanese Pediatric Patients With Short Bowel Syndrome Who Are Dependent on Parenteral Support, Aged 4 Months of Corrected Gestational Age or Older, and Requiring the Dosing of 1.25 mg Formulation), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05027308 phase3completednot on this map

A Phase 3, Open-label Safety Study of Teduglutide in Japanese Pediatric Patients With Short Bowel Syndrome Who Are Dependent on Parenteral Support, Aged 4 Months of Corrected Gestational Age or Older, and Requiring the Dosing of 1.25 mg Formulation

TypeinterventionalSponsorTakedaRan2022 to 2023Enrolled3ConditionsShort Bowel SyndromeArmsTeduglutide
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Kouji MasumotoDepartment of Pediatric Surgery, Institute of Medicine, University of Tsukuba, Tsukuba, Japan.ORCID https://orcid.org/0000-0002-0312-9403
Mitsuru MutoDepartment of Pediatric Surgery, Research Field in Medical and Health Sciences, Medical and Dental Area, Research and Education Assembly, Kagoshima University, Kagoshima, Japan.ORCID https://orcid.org/0000-0003-3272-0785
Takato SasakiDepartment of Pediatric Surgery, Institute of Medicine, University of Tsukuba, Tsukuba, Japan.ORCID https://orcid.org/0000-0001-8936-932X
Mitsuhiro ShikamuraTakeda Pharmaceutical Company Limited, Osaka, Japan.ORCID https://orcid.org/0000-0002-8980-5811
Tomoko TanakaTakeda Pharmaceutical Company Limited, Osaka, Japan.
Sho SakuiTakeda Pharmaceutical Company Limited, Osaka, Japan.
Masakazu MiyamotoTakeda Pharmaceutical Company Limited, Osaka, Japan.
Hiroya NakanoTakeda Pharmaceutical Company Limited, Tokyo, Japan.ORCID https://orcid.org/0000-0002-0952-7090
Taisuke KondoTakeda Pharmaceutical Company Limited, Osaka, Japan.ORCID https://orcid.org/0009-0000-3256-6832
Satoshi IeiriDepartment of Pediatric Surgery, Research Field in Medical and Health Sciences, Medical and Dental Area, Research and Education Assembly, Kagoshima University, Kagoshima, Japan.ORCID https://orcid.org/0000-0002-1250-093X

Funding

Takeda Pharmaceutical Company
6 · The paper itself

Abstract

backgroundPatients with short bowel syndrome (SBS)-associated intestinal failure (SBS-IF) are dependent on parenteral support (PS). In Japan, teduglutide is the only GLP-2 analog medicine indicated for these patients. There are limited data for pediatric patients, especially those with a low body weight. This study evaluated the safety and efficacy of teduglutide in Japanese pediatric patients with SBS-IF (dependence on PS to provide ≥30% of fluid or caloric intake needs) who weighed less than 10 kg.

methodsThis phase 3, open-label study enrolled Japanese pediatric patients with SBS-IF. Patients weighing less than 10 kg received teduglutide 0.05 mg/kg/day subcutaneously in 28-week treatment cycles (24 weeks of teduglutide treatment and 4 weeks of follow-up). Adverse events, changes in PS requirements, and growth parameters were assessed.

resultsThree patients completed the study, with a mean teduglutide exposure duration of 48.9 weeks. All patients experienced treatment-emergent adverse events (TEAEs), but none were related to the study drug or led to death or treatment discontinuation. Clinically meaningful reductions in mean PS volume (13.1%) and mean PS caloric intake (46.6%) were observed at the end of treatment from baseline. One patient achieved a reduction in PS volume of ≥20% at the end of treatment from baseline. Growth parameters showed increases in weight and height/length-for-age z-scores at the end of treatment from baseline.

conclusionIn the three patients with SBS-IF who weighed less than 10 kg, no new safety signals were observed following teduglutide treatment. Clinically meaningful reductions in PS were noted and there was no adverse impact on growth parameters.

trial registrationClinicalTrials.gov registration number: NCT05027308.

Indexed as

Gastrointestinal AgentsParenteral NutritionPeptidesShort Bowel SyndromeBody WeightChildChild, PreschoolFemaleHumansInfantJapanMaleTreatment OutcomeGastrointestinal AgentsPeptidesteduglutideintestinal failureJapanparenteral nutritionpediatricsshort bowel syndrome

Identifiers

PMID41454663
PMCPMC12743259

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.