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NCT02954458 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
A Phase 3 study of Short Bowel Syndrome, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 61
- Enrollment target
- 20
- Study locations
NCT02954458: Completed Phase 3 study of Short Bowel Syndrome, sponsored by Shire.
NCT02954458 is a Phase 3 study of Short Bowel Syndrome that has completed, run by Shire. The registered enrollment target is 61 participants, below the 181-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02954458, a Phase 3 study of Short Bowel Syndrome, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 61 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs that started or worsened on or after the date of first dose of teduglutide for participants in the TED/TED, TED/NTT, and NTT/TED treatment groups, or after the core study baseline visit for participants in the NTT/NTT group.
Conditions Studied
Interventions
- OTHER SOC
- DRUG TED
- DEVICE Syringe
- DEVICE Needle
Study Locations (20)
California
- Childrens Hospital Los Angeles - RHU - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- UCSF Benioff Children's Hospital - San Francisco
New York
- Columbia Unversity Medical Center - New York
- Children's Hosp. at Montefiore - The Bronx
Other
- Helsingin yliopistollinen keskussairaala - Helsinki
- Ospedale Pediatrico Bambino Gesu - Roma
District of Columbia
- Georgetown Children's Research Network - Washington D.C.
Indiana
- Riley Hospital for Children - Indianapolis
Massachusetts
- Boston Children's Hospital - Boston
Nebraska
- The Nebraska Medical Center - Omaha
North Carolina
- Duke Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2017-01-09 |
| Est. Completion | 2020-11-05 |
| Phase | Phase 3 |
What the finished NCT02954458 record still lists
NCT02954458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 181-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Short Bowel Syndrome appearing as the primary indexed condition, and to 4 interventions - of which SOC is the first listed.
NCT02954458 names 20 study sites across 16 states, led by California, New York, Other.
Frequently Asked Questions
What is clinical trial NCT02954458 about?
NCT02954458 is a clinical study titled "Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)". 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, reg...
What is the current status of trial NCT02954458?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2017-01-09. Estimated completion is 2020-11-05.
What conditions does trial NCT02954458 study?
This clinical trial studies the following conditions: Short Bowel Syndrome.
What interventions are being tested in trial NCT02954458?
The interventions under investigation include: SOC (OTHER), TED (DRUG), Syringe (DEVICE), Needle (DEVICE).
Who is sponsoring clinical trial NCT02954458?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02954458 being conducted?
This trial has 20 study locations across California, District of Columbia, Indiana, Massachusetts, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Short Bowel Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02954458's enrollment target sits among peer trials
61 11th of 17 higher than 7 of 17 other Short Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Short Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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