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

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ClinicalTrials.gov Identifier: NCT01952080
Recruitment Status : Completed
First Posted : September 27, 2013
Results First Posted : September 14, 2015
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: teduglutide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Teduglutide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: teduglutide
Open label teduglutide, subcutaneously injected.
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
No Intervention: Standard of Care



Primary Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01952080


  Show 19 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Executive Director Clinical Development, GI NPS Pharma

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01952080     History of Changes
Other Study ID Numbers: TED-C13-003
First Posted: September 27, 2013    Key Record Dates
Results First Posted: September 14, 2015
Last Update Posted: December 8, 2015
Last Verified: July 2015

Keywords provided by Shire:
Short Bowel Syndrome
SBS
Pediatric SBS

Additional relevant MeSH terms:
Syndrome
Short Bowel Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications