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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01952080
First received: September 23, 2013
Last updated: September 19, 2014
Last verified: September 2014

September 23, 2013
September 19, 2014
November 2013
December 2014   (final data collection date for primary outcome measure)
  • 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)
Same as current
Complete list of historical versions of study NCT01952080 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Short Bowel Syndrome
Drug: teduglutide
Experimental: teduglutide
Open label teduglutide, subcutaneously injected.
Intervention: Drug: teduglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
March 2015
December 2014   (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
 
NCT01952080
TED-C13-003
Yes
NPS Pharmaceuticals
NPS Pharmaceuticals
Not Provided
Study Director: Executive Director Clinical Development, GI NPS Pharmaceuticals
NPS Pharmaceuticals
September 2014

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