NCT01021241|UnknownPhase 1
Safety and Efficacy Study of Intravenous Uricase-PEG 20
A Cohort Dose-Escalation Phase 1 Study of Intravenous Infusion of Uricase-PEG 20
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A Cohort Dose-Escalation Phase 1 Study of Intravenous Infusion of Uricase-PEG 20
Sponsor study identifier
interventional
20
1 country
2
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single intravenous doses of Uricase-PEG 20.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
November 24, 2009
Actual (reported)November 26, 2009
Actual (reported)March 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Safety (assessment of signs and symptoms and clinical laboratory measurements following administration of Uricase-PEG 20, graded according to the Common Toxicity Criteria for Rheumatology, version 2.0)
Through Day 35 after dosing
Pharmacokinetics (Uricase-PEG 20 serum concentration)
Through Day 35 after dosing
Pharmacodynamics (plasma uric acid concentration)
Through Day 35 after dosing
Cohorts will receive ascending doses of Uricase-PEG 20 in a sequential manner
Intravenous infusion of Uricase-PEG 20 over one hour; no premedication
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
MRA Clinical Research
Miami, Florida, 33143, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Bomalaski JS, Holtsberg FW, Ensor CM, Clark MA. Uricase formulated with polyethylene glycol (uricase-PEG 20): biochemical rationale and preclinical studies. J Rheumatol. 2002 Sep;29(9):1942-9.
Anthony S Fiorino, MD, PhD
EnzymeRx, LLC
Alan Kivitz, MD
Altoona Center for Clinical Research
First Submitted
November 24, 2009
First Posted
November 26, 2009
Study Start
October 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2010
Estimated (date passed)The Effect of Naproxen on the Pharmacokinetic Profile of LC350189 in Healthy Adults
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 23, 2010
Record last verified: 2010-02
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Source: ClinicalTrials.gov.
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