Status:
COMPLETED
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
Lead Sponsor:
Savient Pharmaceuticals
Conditions:
Chronic Gout Refractory to Conventional Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 le...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00675103
Start Date
May 1 2008
End Date
April 1 2009
Last Update
June 28 2011
Active Locations (4)
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1
University of Chicago- Dept. Biological Services
Chicago, Illinois, United States, 60637
2
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States, 20902
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
Portland Rheumatology Clinic, L.L.C.
Lake Oswego, Oregon, United States, 97035