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Diabetes Mellitus, Type 1

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

Sponsored by Provention Bio, a Sanofi Company

About this trial

Last updated 4 months ago

Study ID

PRV-031-003

Status

Active not recruiting

Type

Observational

Placebo

Yes

Accepting

9 to 19 Years
All Sexes

Trial Timing

Started 5 years ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

1. Completion of the PRV-031-001 (PROTECT) study by completing the Week 78 visit in that study, regardless of how many doses of study drug were administered.

2. Provide written informed consent within 12 months of the Week 78 in the PRV-031-001 study. Written assent will be obtained for participants under 18 years of age at the time of enrollment, according to applicable regulations. If possible, written informed consent and/or assent for the current PROTECT Extension study (PRV-031-003) should be obtained at the final (Week 78) visit in the PROTECT study.

Exclusion Criteria

1. Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.