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NCT01560403 · ClinicalTrials.gov registry record · Phase 3
A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 14
- Enrollment target
NCT01560403: Completed Phase 3 study, sponsored by Shire.
NCT01560403 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 14 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01560403, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.
Primary Outcome
As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.
Interventions
- DRUG Teduglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2012-05-21 |
| Est. Completion | 2013-07-23 |
| Phase | Phase 3 |
What the finished NCT01560403 record still lists
NCT01560403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Teduglutide is the first listed.
NCT01560403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01560403 about?
NCT01560403 is a clinical study titled "A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021". This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.
What is the current status of trial NCT01560403?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 14 participants. The study started on 2012-05-21. Estimated completion is 2013-07-23.
What interventions are being tested in trial NCT01560403?
The interventions under investigation include: Teduglutide (DRUG).
Who is sponsoring clinical trial NCT01560403?
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 NCT01560403's enrollment target sits among peer trials
14 1983rd of 2000 higher than 17 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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