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Phase III

Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab (PROTECT)

  • Study HIC#:2000025596
  • Last Updated:07/15/2021

Brief Summary:

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
  • GenderBoth
  • 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..

Eligibility Criteria

Inclusion Criteria:

  1. Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration.
  2. Has received a diagnosis of T1D according to the criteria from the American Diabetes Association.
  3. Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis.
  4. Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening.
  5. Has a positive result on testing for T1D-related autoantibodies.

Exclusion Criteria:

  1. Has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease.
  2. Has an active infection and/or fever.
  3. 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).
  4. 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.

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