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NCT01952080 · ClinicalTrials.gov registry record · Phase 3
A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 42
- Enrollment target
NCT01952080: Completed Phase 3 study, sponsored by Shire.
NCT01952080 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 42 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01952080, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 42 participants
- Enrollment target
Study 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.
Primary Outcome
Percent change in PN/IV from the Baseline Visit to Week 12 Visit.
Interventions
- DRUG teduglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-11-14 |
| Est. Completion | 2015-01-09 |
| Phase | Phase 3 |
What the finished NCT01952080 record still lists
NCT01952080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which teduglutide is the first listed.
NCT01952080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01952080 about?
NCT01952080 is a clinical study titled "A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome". 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...
What is the current status of trial NCT01952080?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2013-11-14. Estimated completion is 2015-01-09.
What interventions are being tested in trial NCT01952080?
The interventions under investigation include: teduglutide (DRUG).
Who is sponsoring clinical trial NCT01952080?
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 NCT01952080's enrollment target sits among peer trials
42 1877th of 2000 higher than 124 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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