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 Children and Adults with Recent-Onset Type 1 Diabetes Mellitus - Protégé Extensio

• Conditions: Recent-onset type 1 diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus

• Registration Number: EUCTR2008-008432-82-EE
• Lead Sponsor: MacroGenics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 538

Inclusion Criteria

1. Complete Protocol CP-MGA031-01 (i.e., all subjects who complete Study Day 728, regardless of how many doses of study drug are received).

2. Provide written informed consent. Written assent will be obtained for subjects under 18 years of age, according to applicable regulations. If possible, written informed consent and/or assent should be obtained for Protocol CP-MGA031-02 at the last visit in CP-MGA031-01. Informed consent must be obtained after all procedures for Study Day 728 have been completed. The investigator is to give the subject ample time to decide about participation in CP-MGA031-02 by informing the subject of the extension study before the last visit of CP-MGA031-01.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

There are no exclusion criteria for this protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified