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Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout

NCT00111657 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-10-03

Study results available
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Summary

The purpose of this study is to determine whether PEG-uricase (a chemically modified recombinant mammalian enzyme that degrades uric acid) is effective in controlling hyperuricemia in patients with chronic gout, who cannot tolerate, or have not responded adequately, to conventional therapy for gout.

Funding Source - FDA OOPD

Conditions

Interventions

BIOLOGICAL

Pegloticase

8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5

Sponsors & Collaborators

  • Savient Pharmaceuticals

    collaborator INDUSTRY

  • John Sundy

    lead OTHER

Principal Investigators

  • John S. Sundy, MD, PhD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00111657 on ClinicalTrials.gov