Trials / Completed
CompletedNCT01356498
Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 151 (actual)
- Sponsor
- Savient Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies and obtain long-term safety and efficacy data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | pegloticase | 8 mg intravenous infusion |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2010-01-01
- Completion
- 2010-01-01
- First posted
- 2011-05-19
- Last updated
- 2011-12-02
- Results posted
- 2011-12-02
Locations
22 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01356498. Inclusion in this directory is not an endorsement.