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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01952080
First received: September 23, 2013
Last updated: November 10, 2015
Last verified: July 2015

September 23, 2013
November 10, 2015
November 2013
January 2015   (final data collection date for primary outcome measure)
  • Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Percent change in PN/IV from the Baseline Visit to Week 12 Visit.
  • Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment [ Time Frame: Baseline, End of Treatment ] [ Designated as safety issue: No ]
    Percent change in PN/IV from the Baseline Visit to End of Treatment Visit.
  • Percent Change in Parenteral Support (PN/IV) Volume at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    Percent change in PN/IV from the Baseline Visit to Week 16 Visit.
  • Absolute Change in Parenteral Support (PN/IV) Volume at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Absolute change in PN/IV from the Baseline Visit to Week 12 Visit.
  • Absolute Change in Parenteral Support (PN/IV) Volume at End of Treatment [ Time Frame: Baseline, End of Treatment ] [ Designated as safety issue: No ]
    Absolute change in PN/IV from the Baseline Visit to End of Treatment Visit.
  • Absolute Change in Parenteral Support (PN/IV) Volume at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    Absolute change in PN/IV from the Baseline Visit to Week 16 Visit.
  • Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of reported adverse events after 12 weeks of teduglutide
  • Pharmacodynamics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in parenteral support requirements after 12 weeks of teduglutide (liters/week)
  • Pharmacodynamics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in enteral support requirements after 12 weeks of teduglutide (liters/week)
Complete list of historical versions of study NCT01952080 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Percent Change in Enteral Support (EN) Volume From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Percent change in enteral support requirements at Week 12 (liters/week)
  • Percent Change in Enteral Support (EN) Volume From Baseline at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    Percent change in enteral support requirements at Week 16 (liters/week)
  • Absolute Change in Enteral Support (EN) Volume From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    Absolute change in enteral support requirements at Week 12 (liters/week)
  • Absolute Change in Enteral Support (EN) Volume From Baseline at Week 16 [ Time Frame: Baseline, Week 16 ] [ Designated as safety issue: No ]
    Absolute change in enteral support requirements at Week 16 (liters/week)
Not Provided
 
A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
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
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Short Bowel Syndrome
Drug: teduglutide
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
  • Experimental: teduglutide
    Open label teduglutide, subcutaneously injected.
    Intervention: Drug: teduglutide
  • No Intervention: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
January 2015
January 2015   (final data collection date for primary outcome measure)

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)
Both
1 Year to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT01952080
TED-C13-003
Yes
Not Provided
Not Provided
Shire
Shire
Not Provided
Study Director: Executive Director Clinical Development, GI NPS Pharma
Shire
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP