A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
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| ClinicalTrials.gov Identifier: NCT01952080 |
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Recruitment Status :
Completed
First Posted : September 27, 2013
Results First Posted : September 14, 2015
Last Update Posted : June 9, 2021
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Sponsor:
Shire
Information provided by (Responsible Party):
Takeda ( Shire )
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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 |
| Actual Study Start Date : | November 14, 2013 |
| Actual Primary Completion Date : | January 9, 2015 |
| Actual Study Completion Date : | January 9, 2015 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Teduglutide
| Arm | Intervention/treatment |
|---|---|
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Experimental: teduglutide
Open label teduglutide, subcutaneously injected.
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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 :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
- 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)
- 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)
- 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)
- 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)
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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
Locations
Show 19 study locations
Sponsors and Collaborators
Shire
Investigators
| Study Director: | Study Director | Takeda |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Shire |
| ClinicalTrials.gov Identifier: | NCT01952080 |
| Other Study ID Numbers: |
TED-C13-003 |
| First Posted: | September 27, 2013 Key Record Dates |
| Results First Posted: | September 14, 2015 |
| Last Update Posted: | June 9, 2021 |
| Last Verified: | May 2021 |
Keywords provided by Takeda ( Shire ):
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SBS Pediatric SBS Short Bowel Syndrome |
Additional relevant MeSH terms:
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Short Bowel Syndrome Syndrome Disease Pathologic Processes Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Postoperative Complications Teduglutide Gastrointestinal Agents Radiation-Protective Agents Protective Agents Physiological Effects of Drugs |