Trial Profile
Randomized, Multicenter, Double-Blind, Placebo-Controlled Efficacy and Safety Study of 8 mg PEG-Uricase in Two Dose Regimens in Hyperuricemic Subjects With Symptomatic Gout
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 02 Jan 2024
Price :
$35
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At a glance
- Drugs Pegloticase (Primary)
- Indications Gout
- Focus Registrational; Therapeutic Use
- Acronyms GOUT-1
- Sponsors Savient Pharmaceuticals
- 15 Nov 2023 Results of analysis assessing potential baseline factors that may influence urate-lowering response to pegloticas using data from Phase 3 pegloticase registration and MIRROR RCT2 trials presented at the ACR Convergence 2023
- 15 Nov 2023 Results of post-hoc pooled analysis of C0405, C0406, MIRROR OL and MIRROR RCT trials assessing cardiovascular /thromboembolic events after pegloticase initiation, presented at the ACR Convergence 2023.
- 14 Nov 2022 Results of post hoc analysis (n=84) assessing Characteristics and Comorbidity Burden of Phase 3 Clinical Trial Participants Who Did and Did Not Experience Acute Gout Flares During Biweekly Pegloticase Dosing presented at the ACR Convergence 2022