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Safety and Efficacy Study of Intravenous Uricase-PEG 20

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by EnzymeRx.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
EnzymeRx
ClinicalTrials.gov Identifier:
NCT01021241
First received: November 24, 2009
Last updated: February 22, 2010
Last verified: February 2010

November 24, 2009
February 22, 2010
October 2009
March 2010   (final data collection date for primary outcome measure)
  • 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: Through Day 35 after dosing ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics (Uricase-PEG 20 serum concentration) [ Time Frame: Through Day 35 after dosing ] [ Designated as safety issue: No ]
  • Pharmacodynamics (plasma uric acid concentration) [ Time Frame: Through Day 35 after dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01021241 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety and Efficacy Study of Intravenous Uricase-PEG 20
A Cohort Dose-Escalation Phase 1 Study of Intravenous Infusion of Uricase-PEG 20

The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single intravenous doses of Uricase-PEG 20.

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 intravenous Uricase-PEG 20, the anticipated route of administration to be used in future clinical development in tumor lysis syndrome.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gout
  • Hyperuricemia
Biological: Uricase-PEG 20
Intravenous infusion of Uricase-PEG 20 over one hour; no premedication
Experimental: Uricase-PEG 20
Cohorts will receive ascending doses of Uricase-PEG 20 in a sequential manner
Intervention: Biological: Uricase-PEG 20
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
March 2010
March 2010   (final data collection date for primary outcome measure)

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)
Both
40 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01021241
ENZ-101
No
Anthony Fiorino, MD, PhD, EnzymeRx, LLC
EnzymeRx
Not Provided
Study Director: Anthony S Fiorino, MD, PhD EnzymeRx, LLC
Principal Investigator: Alan Kivitz, MD Altoona Center for Clinical Research
EnzymeRx
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP