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NCT01771809 · ClinicalTrials.gov registry record · Phase 2
Long-Term Safety Of PF-00547659 In Ulcerative Colitis
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 330
- Enrollment target
NCT01771809: Completed Phase 2 study, sponsored by Shire.
NCT01771809 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 330 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (148% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01771809, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 330 participants
- Enrollment target
Study Summary
Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.
Primary Outcome
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persi
Interventions
- DRUG 75mg SHP647 (PF-00547659)
- DRUG 225mg SHP647 (PF-00547659)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2013-03-18 |
| Est. Completion | 2017-12-13 |
| Phase | Phase 2 |
What the finished NCT01771809 record still lists
NCT01771809 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (148% higher).
The record links to 0 conditions, and to 2 interventions - of which 75mg SHP647 (PF-00547659) is the first listed.
NCT01771809 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01771809 about?
NCT01771809 is a clinical study titled "Long-Term Safety Of PF-00547659 In Ulcerative Colitis". Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.
What is the current status of trial NCT01771809?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 330 participants. The study started on 2013-03-18. Estimated completion is 2017-12-13.
What interventions are being tested in trial NCT01771809?
The interventions under investigation include: 75mg SHP647 (PF-00547659) (DRUG), 225mg SHP647 (PF-00547659) (DRUG).
Who is sponsoring clinical trial NCT01771809?
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 NCT01771809's enrollment target sits among peer trials
330 145th of 2000 higher than 1,855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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