Skip to main content
OpenTrials
Completed

NCT Number: NCT01952080

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Great Ormond Street Hospital for Children, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Teduglutide

Drug

Open label intervention. Each subject will be assigned to receive 0.0125, 0.025, or 0.05 mg/kg/day for the duration of the study

Primary outcomes

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

    Time frame: Baseline, Week 12

    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

    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

    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

    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

    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

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

Other outcomes

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

    Time frame: Baseline, Week 12

    Percent change in enteral support requirements at Week 12 (liters/week)

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

    Time frame: Baseline, Week 16

    Percent change in enteral support requirements at Week 16 (liters/week)

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

    Time frame: Baseline, Week 12

    Absolute change in enteral support requirements at Week 12 (liters/week)

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

    Time frame: Baseline, Week 16

    Absolute change in enteral support requirements at Week 16 (liters/week)

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

A 12-Week Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects Aged 1 Year Through 17 Years, With Short Bowel Syndrome Who Are Dependent on Parenteral Support

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 27, 2013
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.