Phase 3
N=7
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
Chronic Gout Refractory to Conventional Therapy
Bottom Line
View on ClinicalTrials.gov: NCT00675103 ↗Enrolled (actual)
7
Serious AEs
—
Results posted
Jun 2011
Primary outcome: Primary: Adverse Event Profile — 7; 2 Number of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pegloticase 8 mg i.v. (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Savient Pharmaceuticals
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Event Profile |
7; 2 | — |
| SECONDARY Mean Plasma Uric Acid |
8.5; 4.0; 7.7 | — |
Summary
The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry.
This study is limited to four study centers in the US.
Eligibility Criteria
Inclusion Criteria
- Previous treatment in studies of pegloticase i.v.
- Last exposure to pegloticase i.v. greater than one year prior to study entry
- Symptomatic gout
- Documented hyperuricemic (SUA ≥ 7 mg/dL)
Exclusion Criteria
- Prior exposure to Elitek® (rasburicase)
- Unstable angina
- Uncontrolled arrhythmia or hypertension
- Non-compensated congestive heart failure
- End stage renal disease requiring dialysis
- Concomitant use of SUA lowering agents and use of other investigational drugs
Data sourced from ClinicalTrials.gov (NCT00675103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.