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NCT00920582 · ClinicalTrials.gov registry record · Phase 3

Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

A Phase 3 study, sponsored by MacroGenics.

Terminated
Registry status
Phase 3
Development phase
254
Enrollment target

NCT00920582 is a Phase 3 study that was terminated before completion, run by MacroGenics. The registered enrollment target is 254 participants.

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The verdict

NCT00920582, a Phase 3 study, was terminated before completion, sponsored by MacroGenics.

TERMINATED
Registry status
Phase 3
Development phase
254 participants
Enrollment target

Study Summary

The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.

Interventions

  • DRUG Placebo
  • BIOLOGICAL Teplizumab Herold Regimen
  • BIOLOGICAL Teplizumab 33.3% Herold Regimen
  • BIOLOGICAL Teplizumab Curtailed Herold Regimen

Trial Details

FieldValue
Enrollment Target 254 participants
Start Date 2009-09
Est. Completion 2012-07
Phase Phase 3

Sponsor

MacroGenics

36 total trials

What the Registry Record Tells You About NCT00920582

The ClinicalTrials.gov registry entry for NCT00920582 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 254 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MacroGenics, which has 36 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00920582 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00920582 about?

NCT00920582 is a clinical study titled "Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus". The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.

What is the current status of trial NCT00920582?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 254 participants. The study started on 2009-09. Estimated completion is 2012-07.

What interventions are being tested in trial NCT00920582?

The interventions under investigation include: Placebo (DRUG), Teplizumab Herold Regimen (BIOLOGICAL), Teplizumab 33.3% Herold Regimen (BIOLOGICAL), Teplizumab Curtailed Herold Regimen (BIOLOGICAL).

Who is sponsoring clinical trial NCT00920582?

This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.