Trials / Completed
CompletedNCT02954458
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
A Prospective, Open-label, Long-term Safety and Efficacy Study of Teduglutide in Pediatric Patients With Short Bowel Syndrome Who Completed TED-C14-006 or SHP633-301
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study will follow participants who completed the TED-C14-006 study. The purpose of this study is to evaluate the long-term safety and efficacy of teduglutide in pediatric participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide treatment to eligible participants, regardless of treatment received in TED-C14-006 or SHP633-301.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TED | 0.05 mg/kg SC injection once daily. |
| OTHER | SOC | Standard safety assessments and adjustments in nutritional support. |
| DEVICE | Syringe | Teduglutide will be administered using syringe. |
| DEVICE | Needle | Teduglutide will be administered using needle. |
Timeline
- Start date
- 2017-01-09
- Primary completion
- 2020-11-05
- Completion
- 2020-11-05
- First posted
- 2016-11-03
- Last updated
- 2025-03-28
- Results posted
- 2021-10-13
Locations
22 sites across 6 countries: United States, Belgium, Canada, Finland, Italy, United Kingdom
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02954458. Inclusion in this directory is not an endorsement.