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Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients

NCT00675103 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2011-06-28

Study results available
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Summary

The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry.

This study is limited to four study centers in the US.

Conditions

  • Chronic Gout Refractory to Conventional Therapy

Interventions

DRUG

pegloticase 8 mg i.v.

pegloticase 8 mg i.v. every 2 weeks for 24 weeks

Sponsors & Collaborators

  • Savient Pharmaceuticals

    lead INDUSTRY

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
2008-05-31
Primary Completion
2009-01-31
Completion
2009-04-30

Countries

  • United States

Study Locations

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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 NCT00675103 on ClinicalTrials.gov