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Safety and Efficacy Study of Intramuscular Uricase-PEG 20

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038947
Recruitment Status : Unknown
Verified December 2009 by EnzymeRx.
Recruitment status was:  Recruiting
First Posted : December 24, 2009
Last Update Posted : December 24, 2009
Information provided by:

Brief Summary:
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single and multiple intramuscular doses of Uricase-PEG 20

Condition or disease Intervention/treatment Phase
Gout Hyperuricemia Biological: Uricase-PEG 20 Phase 1

Detailed Description:
Uricase is an enzyme (found in most mammals but not humans) that converts poorly soluble uric acid into highly soluble allantoin. Because humans lack uricase, they are prone to develop elevated levels of uric acid, which can form crystals in the joints and soft tissues. In those which chronically elevated uric acid, gout may develop. In the setting of acute rises in uric acid, seen for example in tumor lysis syndrome, uric acid crystals can damage the renal tubules. Uricase-PEG 20 is a recombinant uricase conjugated with multiple PEG molecules designed to prolong the half-life and decrease the immunogenicity of uricase. This study will characterize the safety, pharmacokinetics and pharmacodynamics of intramuscular Uricase-PEG 20, the anticipated route of administration to be used in future clinical development in gout.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Cohort Dose-Escalation Phase 1 Study of Intramuscular Injection of Uricase-PEG 20
Study Start Date : December 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout

Arm Intervention/treatment
Experimental: Uricase-PEG 20
Cohorts will receive ascending doses of Uricase-PEG 20 in a sequential manner. The study will enroll both single dose cohorts and multi-dose cohorts.
Biological: Uricase-PEG 20
Intramuscular injection of Uricase-PEG 20 without premedication

Primary Outcome Measures :
  1. 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) [ Time Frame: Up to 35 days after dosing ]

Secondary Outcome Measures :
  1. Pharmacokinetics (Uricase-PEG 20 serum concentration) [ Time Frame: Up to 35 days after dosing ]
  2. Pharmacodynamics (plasma uric acid concentration) [ Time Frame: Up to 35 days after dosing ]
  3. Immunogenicity [ Time Frame: Up to 35 days after dosing ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Serum uric acid > 6 mg/dL (men) or > 5 mg/dL (women)
  • Clinical laboratory values within normal limits or not clinically significant
  • Women should be menopausal or peri-menopausal

Exclusion Criteria:

  • Prior exposure to uricase
  • History of severe allergic reactions, or any allergy to PEG or pegylated products
  • G6PD or catalase deficiency
  • Medical condition that may interfere with ability to complete the study (e.g., uncontrolled diabetes or hypertension, congestive heart failure NYHA Class III or IV, history of myocardial infarction, immunosuppression, pregnancy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01038947

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Contact: Rocelle Flores 201-843-4424 ext 203

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United States, Florida
MRA Clinical Research Recruiting
Miami, Florida, United States, 33143
Contact: Vivian Rosales    305-772-2857   
Principal Investigator: Patricia Pardo, MD         
United States, Pennsylvania
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: Ellen Kivitz    814-693-0300 ext 224      
Principal Investigator: Alan J Kivitz, MD         
Sponsors and Collaborators
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Study Director: Anthony S Fiorino, MD, PhD EnzymeRx, LLC
Principal Investigator: Patricia Pardo, MD MRA Clinical Research

Additional Information:
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Responsible Party: Anthony Fiorino, MD, PhD, EnzymeRx, LLC Identifier: NCT01038947    
Other Study ID Numbers: ENZ-102
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: December 24, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Pathologic Processes