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
Recruitment status was Active, not recruiting
Sponsor:
EnzymeRx
Information provided by:
EnzymeRx
ClinicalTrials.gov Identifier:
NCT01021241
First received: November 24, 2009
Last updated: February 22, 2010
Last verified: February 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 24, 2009 | ||||||||
| Last Updated Date | February 22, 2010 | ||||||||
| Start Date ICMJE | October 2009 | ||||||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01021241 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety and Efficacy Study of Intravenous Uricase-PEG 20 | ||||||||
| Official Title ICMJE | A Cohort Dose-Escalation Phase 1 Study of Intravenous Infusion of Uricase-PEG 20 | ||||||||
| Brief Summary | The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single intravenous doses of Uricase-PEG 20. |
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| 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 intravenous Uricase-PEG 20, the anticipated route of administration to be used in future clinical development in tumor lysis syndrome. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Biological: Uricase-PEG 20
Intravenous infusion of Uricase-PEG 20 over one hour; no premedication |
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| Study Arm (s) | Experimental: Uricase-PEG 20
Cohorts will receive ascending doses of Uricase-PEG 20 in a sequential manner
Intervention: Biological: Uricase-PEG 20 |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | March 2010 | ||||||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 40 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01021241 | ||||||||
| Other Study ID Numbers ICMJE | ENZ-101 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Anthony Fiorino, MD, PhD, EnzymeRx, LLC | ||||||||
| Study Sponsor ICMJE | EnzymeRx | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | EnzymeRx | ||||||||
| Verification Date | February 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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