Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab (PROTECT)
- Study HIC#:2000025596
- Last Updated:07/15/2021
The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks..
Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.
- Age8 years - 17 years
- Start Date09/10/2019
- End Date05/31/2022
Trial Purpose and Description
The purpose of this study is to determine whether teplizumab slows the loss of B cells and preserves B cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks..
- Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration.
- Has received a diagnosis of T1D according to the criteria from the American Diabetes Association.
- Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis.
- Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening.
- Has a positive result on testing for T1D-related autoantibodies.
- 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).
- An individual who has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.