WHO ICTRP trial

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm…

NL-OMON33995 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting

Key facts

Trial ID NL-OMON33995
Public title A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus
Scientific title A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus - Protégé…
Primary sponsor MacroGenics Inc.
Registry Overview of Medical Research in the Netherlands (NL-OMON)
Recruitment status Not Recruiting
Study type Interventional
Phase 2
Countries The Netherlands
Conditions diabetes;10003816;diabetes
Interventions The study group will get the study drug administered intravenous 24 times. The control group will get the study drug administered intravenous 24 times. Both groups will undergo a venipuncture 29 times. ;diabetes mellitus type 1;monoclonal…
Registration date Jun 23, 2009
Target size 20
Secondary IDs 2006-002457-69;NCT00385697;NL22283.078.08
Registry page onderzoekmetmensen.nl

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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date:

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