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NCT02949362 · ClinicalTrials.gov registry record · Phase 3
Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 29
- Enrollment target
NCT02949362: Completed Phase 3 study, sponsored by Shire.
NCT02949362 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 29 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02949362, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 29 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term period. It will evaluate how these children fared after the TED-C13-003 study ended. This study will also offer teduglutide treatment to eligible subjects, regardless of treatment received in TED-C13-003.
Primary Outcome
An 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. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incap
Interventions
- OTHER SOC
- DRUG Teduglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2016-12-09 |
| Est. Completion | 2020-07-14 |
| Phase | Phase 3 |
What the finished NCT02949362 record still lists
NCT02949362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which SOC is the first listed.
NCT02949362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02949362 about?
NCT02949362 is a clinical study titled "Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study". The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term period. It will evaluate how these children fared after the TED-C13-003 study ended. This study will also offer t...
What is the current status of trial NCT02949362?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 29 participants. The study started on 2016-12-09. Estimated completion is 2020-07-14.
What interventions are being tested in trial NCT02949362?
The interventions under investigation include: SOC (OTHER), Teduglutide (DRUG).
Who is sponsoring clinical trial NCT02949362?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02949362's enrollment target sits among peer trials
29 1933rd of 2000 higher than 66 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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