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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02954458
The ClinicalTrials.gov registry entry for NCT02954458 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 181-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (66% lower). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
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