Teplizumab in Pediatric Stage 2 Type 1 Diabetes (PETITE-T1D)
Type 1 Diabetes
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Stage 2 T1D, Pediatric T1D
Eligibility Criteria
Inclusion Criteria: Participant is a male or female 0 to < 8 years of age, inclusive, at Day 1 Participant has Stage 2 T1D (two T1D-related autoantibodies and dysglycemia) Exclusion Criteria: Participant has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease Has an active infection and/or fever Has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Has any condition that, in the opinion of the Investigator, would interfere with the study conduct or the safety of the participant.
Sites / Locations
- Clinical Site 107Recruiting
- Clinical Site 102Recruiting
- Clinical Site 101Recruiting
- Clinical Site 104Recruiting
- Clinical Site 110Recruiting
- Clinical Site 105Recruiting
- Site 109Recruiting
- Clinical Site 103Recruiting
Arms of the Study
Arm 1
Experimental
teplizumab injection
teplizumab injection, sterile solution for intravenous use