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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 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 42 participants.
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.
Interventions
- DRUG teduglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-11-14 |
| Est. Completion | 2015-01-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01952080
The ClinicalTrials.gov registry entry for NCT01952080 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which teduglutide is the first listed.
NCT01952080 reports 0 study locations.
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.
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