Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
Multicenter, Open-Label, 24 Week Regimen of 8 mg Pegloticase i.v. in Symptomatic Gout Subjects Who Participated in Previous Studies of Pegloticase i.v.
1 other identifier
interventional
7
1 country
4
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 least one year before study entry. This study is limited to four study centers in the US.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2008
Shorter than P25 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 6, 2008
CompletedFirst Posted
Study publicly available on registry
May 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
June 28, 2011
CompletedJune 28, 2011
June 1, 2011
8 months
May 6, 2008
June 7, 2011
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Event Profile
Number of participants reporting events
6 months
Secondary Outcomes (1)
Mean Plasma Uric Acid
Baseline, Week 3 and Week 7
Study Arms (1)
pegloticase
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Chicago- Dept. Biological Services
Chicago, Illinois, 60637, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Portland Rheumatology Clinic, L.L.C.
Lake Oswego, Oregon, 97035, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Savient Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 6, 2008
First Posted
May 8, 2008
Study Start
May 1, 2008
Primary Completion
January 1, 2009
Study Completion
April 1, 2009
Last Updated
June 28, 2011
Results First Posted
June 28, 2011
Record last verified: 2011-06