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Safety and Efficacy Study of Intramuscular Uricase-PEG 20

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
EnzymeRx

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.

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

Drug Information available for: Rasburicase
U.S. FDA Resources

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT01038947


Contacts
Contact: Rocelle Flores 201-843-4424 ext 203 rflores@enzymerx.com

Locations
United States, Florida
MRA Clinical Research Recruiting
Miami, Florida, United States, 33143
Contact: Vivian Rosales    305-772-2857    vrosales@miamiresearch.com   
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
EnzymeRx
Investigators
Study Director: Anthony S Fiorino, MD, PhD EnzymeRx, LLC
Principal Investigator: Patricia Pardo, MD MRA Clinical Research

Additional Information:
Publications:
Responsible Party: Anthony Fiorino, MD, PhD, EnzymeRx, LLC
ClinicalTrials.gov Identifier: NCT01038947     History of Changes
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:
Hyperuricemia
Pathologic Processes
Rasburicase
Gout Suppressants
Antirheumatic Agents