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NCT02598596 · ClinicalTrials.gov registry record · Phase 2

Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect

A Phase 2 study, sponsored by Ampel BioSolutions.

Completed
Registry status
Phase 2
Development phase
132
Enrollment target

NCT02598596: Completed Phase 2 study, sponsored by Ampel BioSolutions.

NCT02598596 is a Phase 2 study that has completed, run by Ampel BioSolutions. The registered enrollment target is 132 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02598596, a Phase 2 study, has completed, sponsored by Ampel BioSolutions.

COMPLETED
Registry status
Phase 2
Development phase
132 participants
Enrollment target

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.

Primary Outcome

Determine response rate; the last 3 consecutive levels of SUA must be \<6 mg/dL

Interventions

  • DRUG Azathioprine
  • BIOLOGICAL Pegloticase

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2015-12
Est. Completion 2020-04-27
Phase Phase 2
Ampel BioSolutions

3 total trials

What the finished NCT02598596 record still lists

NCT02598596 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Azathioprine is the first listed.

NCT02598596 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02598596 about?

NCT02598596 is a clinical study titled "Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect". 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.

What is the current status of trial NCT02598596?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2015-12. Estimated completion is 2020-04-27.

What interventions are being tested in trial NCT02598596?

The interventions under investigation include: Azathioprine (DRUG), Pegloticase (BIOLOGICAL).

Who is sponsoring clinical trial NCT02598596?

This trial is sponsored by Ampel BioSolutions, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02598596's enrollment target sits among peer trials

132 539th of 2000 higher than 1,460 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02598596, the US trial registry maintained by the National Library of Medicine. NCT02598596 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.