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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome

NCTNCT01952080 (opens ClinicalTrials.gov in a new tab)Other idTED-C13-003
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
42 participants (actual)
Sponsor
Shire · Industry
Design
Not randomized · Open label (no masking)
Countries
2 countries

United States, United Kingdom

Start
14 Nov 2013
Primary completion
9 Jan 2015
Completion
9 Jan 2015
First posted
27 Sept 2013 (estimated)
Last update posted
9 Jun 2021
Conditions
Short Bowel Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 3

    A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome

    NCT01952080

    14 Nov 2013 to 9 Jan 2015

Registry summary

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

This will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into an observational cohort who will receive standard of care. Three doses of teduglutide are to be investigated for 12 weeks. All subjects will be screened prior to the start of treatment (SOT) to establish baseline characteristics including safety, eligibility and nutritional support parameters.

Interventions

  • teduglutideDrug

Arms2

  • Experimental

    teduglutide

    Open label teduglutide, subcutaneously injected.

  • No intervention

    Standard of Care

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12

    Time frame · Baseline, Week 12

    Registry description

    Percent change in PN/IV from the Baseline Visit to Week 12 Visit.

  2. Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment

    Time frame · Baseline, End of Treatment

    Registry description

    Percent change in PN/IV from the Baseline Visit to End of Treatment Visit.

  3. Percent Change in Parenteral Support (PN/IV) Volume at Week 16

    Time frame · Baseline, Week 16

    Registry description

    Percent change in PN/IV from the Baseline Visit to Week 16 Visit.

  4. Absolute Change in Parenteral Support (PN/IV) Volume at Week 12

    Time frame · Baseline, Week 12

    Registry description

    Absolute change in PN/IV from the Baseline Visit to Week 12 Visit.

  5. Absolute Change in Parenteral Support (PN/IV) Volume at End of Treatment

    Time frame · Baseline, End of Treatment

    Registry description

    Absolute change in PN/IV from the Baseline Visit to End of Treatment Visit.

  6. Absolute Change in Parenteral Support (PN/IV) Volume at Week 16

    Time frame · Baseline, Week 16

    Registry description

    Absolute change in PN/IV from the Baseline Visit to Week 16 Visit.

Posted results

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

Primary outcome results

Primary outcomeMean· Baseline, Week 12

Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12

GroupValue (percent change)Spread
Standard of Care7.3812.756
Teduglutide 0.0125 mg/kg/Day-9.9521.625
Teduglutide 0.025 mg/kg/Day-37.3426.422
Teduglutide 0.05 mg/kg/Day-39.1140.792
Primary outcomeMean· Baseline, End of Treatment

Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment

GroupValue (percent change)Spread
Standard of Care7.3812.756
Teduglutide 0.0125 mg/kg/Day-8.6020.380
Teduglutide 0.025 mg/kg/Day-35.6126.198
Teduglutide 0.05 mg/kg/Day-36.5040.585
Primary outcomeMean· Baseline, Week 16

Percent Change in Parenteral Support (PN/IV) Volume at Week 16

GroupValue (percent change)Spread
Standard of Care3.9216.616
Teduglutide 0.0125 mg/kg/Day-11.2521.196
Teduglutide 0.025 mg/kg/Day-33.8527.017
Teduglutide 0.05 mg/kg/Day-31.8039.264
Primary outcomeMean· Baseline, Week 12

Absolute Change in Parenteral Support (PN/IV) Volume at Week 12

GroupValue (Liters/week)Spread
Standard of Care0.430.746
Teduglutide 0.0125 mg/kg/Day-0.500.910
Teduglutide 0.025 mg/kg/Day-2.781.985
Teduglutide 0.05 mg/kg/Day-2.573.564
Secondary and other outcome results(4)
Other pre specified outcomeMean· Baseline, Week 12

Percent Change in Enteral Support (EN) Volume From Baseline at Week 12

GroupValue (percent change)Spread
Standard of Care16.8214.921
Teduglutide 0.0125 mg/kg/Day23.5022.060
Teduglutide 0.025 mg/kg/Day50.9361.416
Teduglutide 0.05 mg/kg/Day57.9644.953
Other pre specified outcomeMean· Baseline, Week 16

Percent Change in Enteral Support (EN) Volume From Baseline at Week 16

GroupValue (percent change)Spread
Standard of Care52.0666.194
Teduglutide 0.0125 mg/kg/Day60.30–
Teduglutide 0.025 mg/kg/Day43.9878.599
Teduglutide 0.05 mg/kg/Day58.9363.927
Other pre specified outcomeMean· Baseline, Week 12

Absolute Change in Enteral Support (EN) Volume From Baseline at Week 12

GroupValue (Liters/week)Spread
Standard of Care0.690.715
Teduglutide 0.0125 mg/kg/Day2.674.412
Teduglutide 0.025 mg/kg/Day2.643.220
Teduglutide 0.05 mg/kg/Day0.971.127
Other pre specified outcomeMean· Baseline, Week 16

Absolute Change in Enteral Support (EN) Volume From Baseline at Week 16

GroupValue (Liters/week)Spread
Standard of Care0.840.624
Teduglutide 0.0125 mg/kg/Day4.565.384
Teduglutide 0.025 mg/kg/Day2.473.403
Teduglutide 0.05 mg/kg/Day0.910.968

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Standard of CareSOC- no teduglutide therapy–3 / 55 / 5
Teduglutide 0.0125 mg/kg/DayCohort 1 - Teduglutide 0.0125 mg/kg/day–3 / 88 / 8
Teduglutide 0.025 mg/kg/DayCohort 2 - Teduglutide 0.025 mg/kg/day–6 / 1414 / 14
Teduglutide 0.05 mg/kg/DayCohort 3 - Teduglutide 0.05 mg/kg/day–8 / 1515 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

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

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Clinical trial · 2023

3 results

Effects of Teduglutide on Diarrhea in Pediatric Patients with Short Bowel Syndrome-Associated Intestinal Failure.

Fifi et al. 2023Journal of pediatric gastroenterology and nutritioncited by 5

PMID 37889619PMC10583903DOI 10.1097/mpg.0000000000003922PUB-37889619

Free to read · publisher termsCC BY-NC-ND3 results
Read at sourceSee results (3)

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
Publisher pageSee results (13)

Eligibility

Who could join, as posted.

Sex
All
Age
from 1 Year up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Key Inclusion Criteria: * Current history of SBS as a result of major intestinal resection, (eg, due to necrotizing enterocolitis, midgut volvulus, intestinal atresia, or gastroschisis) for at least 12 months prior to screening * Short bowel syndrome that requires parenteral nutrition/intravenous (PN/IV) support * Stable PN/IV support for at least 3 months prior to enrollment based upon the opinion of the investigator Key Exclusion Criteria: * Serial transverse enteroplasty or any other bowel lengthening procedure performed within the past 3 months * Unstable absorption due to cystic fibrosis, untreated Hirschsprung's disease or known DNA abnormalities (ie, Familial Adenomatous Polyposis, Fanconi syndrome) * Evidence of obstruction on upper gastrointestinal (GI) series done within 6 months prior to screening * Major gastrointestinal surgical intervention within 3 months prior to screening (insertion of feeding tube or endoscopic procedure is allowed)

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