Clinical trial
The Protégé Study - Clinical Trial of MGA031 in Children and Adults With…
NCT00385697 · MacroGenics, Industry · Completed
Key facts
| NCT number | NCT00385697 |
|---|---|
| Title | The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus |
| Official title | A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus |
| Lead sponsor | MacroGenics, Industry |
| Collaborators | Eli Lilly and Company Industry |
| Status | Completed |
| Phase | Phase 2/Phase 3 |
| Study type | Interventional |
| Conditions | Type 1 Diabetes Mellitus |
| Intervention type | Biological, Drug |
| Interventions | Teplizumab, Placebo |
| Enrollment | 554 |
| Start date | Oct 1, 2006 |
| Primary completion | Jun 1, 2010 |
| Completion | Aug 1, 2011 |
| First posted | Oct 11, 2006 |
| Last update posted | Dec 5, 2023 |
| Countries | Canada, Czechia, Estonia, Germany, India, Israel, Latvia, Mexico, Netherlands, Poland, Romania, Spain and 4 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: