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Trial · Observational

CompletedPhase not statedRegistry data

Pediatric Teduglutide Registry

Short name PTR

Overview

Status
Completed
Phase
Phase not stated
Enrollment
142 participants (actual)
Sponsor
Boston Children's Hospital · Other
Design
Not stated
Countries
1 country

United States

Start
18 May 2021
Primary completion
31 Aug 2023
Completion
31 Aug 2023
First posted
5 Apr 2021
Last update posted
11 Dec 2023
Conditions
Short Bowel Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph –

    PTR

    NCT04832087

    18 May 2021 to 31 Aug 2023

Registry summary

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

Pediatric specific post-marketing registry to evaluate the long-term safety and efficacy of teduglutide.

Interventions

  • TeduglutideDrug

Arms2

  • Other

    Cohort A

    Participants with SBS who started Teduglutide after FDA approval (May 2019)

  • Other

    Cohort B

    Subjects who participated in any of the teduglutide pediatric clinical trial studies (TED-C13-003, TED-C14-006, SHP633-303, or SHP633-304) and subsequently started therapy with teduglutide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent change in calories from parenteral support (PS) (Kcal/kg/day)

    Time frame · Up to 3 years

    Registry description

    Maximum percent change in calories (energy intake in kcal/kg/day) from parenteral support relative to pre- treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A.

Secondary outcomes(7)
  1. Percent change of (PS) volume (liters/week)

    Time frame · Up to 3 years

    Registry description

    Percent change of PS volume (liters/week) relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A

  2. Percent change of PS infusions (number of days/week )

    Time frame · Up to 3 years

    Registry description

    Percent change of PS infusions (number of days/week relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A

  3. Proportion of subjects completely weaned from PS

    Time frame · Up to 3 years

    Registry description

    Number (proportion) of children who wean completely from PS within 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A.

  4. Adverse Events

    Time frame · Up to 3 years

    Registry description

    Number (proportion) of subjects with adverse events among Cohort A. Number (proportion) of subjects with adverse events among Cohort B.

  5. Weight-for-age Z-score (WAZ)

    Time frame · Up to 3 years

    Registry description

    Mean change in Weight-for-age Z-score (WAZ), relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A.

  6. Height-for-age-Z-score (HAZ)

    Time frame · Up to 3 years

    Registry description

    Mean change in Height-for-age-Z-score (HAZ), relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A.

  7. Body-Mass-Index Z-score (BMIZ)

    Time frame · Up to 3 years

    Registry description

    Mean change in Body-Mass-Index Z-score (BMIZ), relative to pre-treatment (baseline) assessment up to 6 months, 1 year, 2 years and 3 years from start of therapy among Cohort A.

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.

Completed trials do not always post results.

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

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

PubMed tag: none · 2020

19 results

Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III Study.

Kocoshis et al. 2020JPEN. Journal of parenteral and enteral nutritioncited by 98

PMID 31495952PMC7318247DOI 10.1002/jpen.1690PUB-31495952

Free to read · publisher termsCC BY-NC19 results

Indexing hint: Clinical trial · 2017

13 results

Outcomes from a 12-Week, Open-Label, Multicenter Clinical Trial of Teduglutide in Pediatric Short Bowel Syndrome.

Carter et al. 2017The Journal of pediatricscited by 135

PMID 27855998DOI 10.1016/j.jpeds.2016.10.027PUB-27855998

Full text at the publisher13 results

More studies

1 study on this page

PubMed tag: none · 2026

Safety and long-term effectiveness of teduglutide in children with intestinal failure due to short bowel syndrome: a multicenter, post-marketing cohort study.

Jimenez et al. 2026Pediatric research

PMID 42754721DOI 10.1038/s41390-026-05489-0PUB-42754721

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 1 Year
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Cohort A: Inclusion Criteria: 1. Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days 2. Received teduglutide after FDA approval 3. Age ≥ 1 years and ≤ 18 years at start of teduglutide initiation 4. Weight ≥ 10 kg at start of teduglutide initiation 5. Dependent on PS at the time of teduglutide initiation 6. Subject data for primary outcome (PS energy intake in cal/kg/day) is available for medical chart abstraction at baseline (pretreatment) visit. 7. The subject or guardian signs and dates a written informed consent form and any required privacy authorization and minor provides any assent required prior to enrolment into the registry. Exclusion Criteria: 1. Participation in the pediatric clinical trial studies of teduglutide (TED-C13-003, TED-C14-006 or SHP633-303, SHP633-304). 2. In the opinion of the investigator, the subject or guardian is at high risk for non-compliance. Cohort B: Inclusion Criteria: 1. Diagnosis of SBS defined as intestinal resection for congenital or acquired intestinal disease leading to dependence on PS for 90 days 2. Participated in clinical trial study (TED-C13-003, TED-C14-006) and/or extension study (SHP633-303, SHP633-304) 3. Currently receiving teduglutide 4. The subject or guardian signs and dates a written informed consent form and any required privacy authorization and minor provides any assent required prior to enrolment into the registry. Exclusion Criteria: 1\. In the opinion of the investigator, the subject or guardian is at high risk for non-compliance.

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