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Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Recent-Onset Type 1 Diabetes Mellitus

Clinical Trial Summary

The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study.

Clinical Trial Description

This study is the long-term extension of the PRV-031-001 (PROTECT) study. PROTECT is a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center study to evaluate the efficacy and safety of teplizumab, a humanized, anti-CD3 monoclonal antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1 diabetes (within 6 weeks of diagnosis) in which approximately 300 participants were randomized at a ratio of 2:1 to the teplizumab or placebo and received two courses of treatment administered 6 or 12 months apart with final follow-up at approximately 18 months (78 weeks) after the first dose. Participants who complete the PROTECT study are invited to enroll in this observational, extension study to collect long-term safety and other clinical data. The decision to participate can be made within 12 months of completing the PROTECT study. No study drug will be administered during this extension study. Participants will continue to receive standard care for type 1 diabetes from their primary physicians. Participants will return to the study sites for assessments once every 6 months through Month 42. Therefore, the combined duration of the PROTECT and PROTECT Extension studies will be 60 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04598893
Study type Observational
Source Sanofi
Contact
Status Active, not recruiting
Phase
Start date October 26, 2020
Completion date November 2026
View Details
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