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Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect

NCT02598596 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2021-10-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of pegloticase on clinical outcome, as defined by an serum uric acid level \<6 mg/dL, in patients with chronic, refractory gout.

Conditions

Interventions

BIOLOGICAL

Pegloticase

Pegloticase, IV

DRUG

Azathioprine

Azathioprine (1.25 mg/kg, followed by 2.5 mg/kg) oral, daily

Sponsors & Collaborators

  • IND 2 Results LLC

    collaborator INDUSTRY

  • Ampel BioSolutions, LLC

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2020-04-13
Completion
2020-04-27

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 NCT02598596 on ClinicalTrials.gov