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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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