interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development
EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).
The EU Clinical Trials Register currently displays
44334
clinical trials with a EudraCT protocol, of which
7366
are clinical trials conducted with subjects less than 18 years old.
The register also displays information on
18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see
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5 result(s) found for: Teplizumab (MGA031).
Displaying page 1 of 1.
EudraCT Number: 2009-011606-41
Sponsor Protocol Number: CP-MGA031-03
Start Date*: 2009-09-15
Sponsor Name:MacroGenics, Inc.
Full Title: A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in C...
Medical condition: Recent-onset type 1 diabetes mellitus
Disease:
Version
SOC Term
Classification Code
Term
Level
14.1
10027433 - Metabolism and nutrition disorders
10045228
Type I diabetes mellitus
LLT
Population Age: Children, Adolescents, Under 18, Adults
Full Title: A prospective, multi-center, Phase 1b/2a study to assess the safety and tolerability of different doses of AG019 administered alone or in association with teplizumab in patients with clinical recen...
Medical condition: Recent-onset Type 1 Diabetes mellitus (T1D)
Full 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-C...
Medical condition: Recent-onset type I diabetes mellitus (T1DM)
Full Title: A Multicenter, Multinational Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Chi...
Medical condition: Recent-onset type 1 diabetes mellitus
Disease:
Version
SOC Term
Classification Code
Term
Level
9.1
10045228
Type I diabetes mellitus
LLT
Population Age: Children, Adolescents, Under 18, Adults
Full Title: Anti-CD3 mAb (teplizumab) for prevention of diabetes in relatives at-risk for Type 1 diabetes mellitus
Medical condition: Anti-CD3 monoclonal antibody is to be used for the prevention of type 1 diabetes mellitus in relatives at risk for developing the disease.
Disease:
Version
SOC Term
Classification Code
Term
Level
20.1
10042613 - Surgical and medical procedures
10066284
Diabetes prophylaxis
PT
Population Age: Children, Adolescents, Under 18, Adults
Gender: Male, Female
Trial protocol:DE(Completed)GB(GB - no longer in EU/EEA)IT(Completed)
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