Trials / Completed
CompletedNCT01771809
Long-Term Safety Of PF-00547659 In Ulcerative Colitis
A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 330 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years – 66 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 75mg SHP647 (PF-00547659) | 75 mg sterile liquid injected subcutaneously every 4 weeks. |
| DRUG | 225mg SHP647 (PF-00547659) | 225 mg sterile liquid injected subcutaneously every 4 weeks. |
Timeline
- Start date
- 2013-03-18
- Primary completion
- 2017-12-13
- Completion
- 2017-12-13
- First posted
- 2013-01-18
- Last updated
- 2021-06-03
- Results posted
- 2019-04-18
Locations
99 sites across 21 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Russia, Serbia, Slovakia, South Africa, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01771809. Inclusion in this directory is not an endorsement.