PETITE-T1D

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The purpose of this study is to evaluate the safety and pharmacokinetics (drug levels in the blood) of teplizumab in children less than 8 years old. The study will also assess if your child stays in Stage 2 T1D or progresses to Stage 3 T1D. Your child may join the study only if they are in Stage 2 T1D.

Previous studies in adults and children older than 8 years of age suggest that taking teplizumab, a drug that affects your child's immune system, may stop, delay, or decrease the attack on the cells that make insulin. This slowing or blocking of the immune attack may reduce the risk of short-term and long-term consequences of T1D.

To join this study, your child must have been diagnosed with Stage 2 T1D based on two positive T1D-related antibodies and confirmed dysglycemia (abnormal blood sugar levels) based on an oral glucose tolerance test, fasting plasma glucose test, or an increase in a blood test called the hemoglobin A1c.

The study is "open-label." That means that if your child qualifies for the study, your child will receive teplizumab. There is no placebo in this study.

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at t1dmresearch [at] chop.edu or 215-590-5007.

ClinicalTrials.gov Identifier

NCT05757713

View full trial information on ClinicalTrials.gov

Eligibility & Criteria

IRB #:
23-020777
Official Title:
Teplizumab in Pediatric Stage 2 Type 1 Diabetes (PETITE-T1D)
Study Phase:
Phase IV
Eligible Age Range:
0 - 8 Years
Gender:
All
Study Categories:

Visit Criteria

Detailed Description: This is a multicenter study in the U.S. to assess the safety and pharmacokinetics of teplizumab in pediatric participants with Stage 2 type 1 diabetes (T1D) (two T1D-related autoantibodies and dysglycemia) who are 0 to <8 years of age. The study treatment consists of an intravenous infusion of teplizumab once daily for 14 consecutive days. The study duration for each individual may last up to approximately 26 months.

Visit 1 - Screening visit (3-6 hours)

  • Eligibility check, sign informed consent, review medical history and current medications, vital signs, physical exam, and blood and urine tests.
  • Serum pregnancy test for females of childbearing potential.
  • Potential OGTT test

Visits 2 -15 Administer Teplizumab and Monitor (3-5 hours for 14 days in a row)

  • Review medical history and current medications, measure height, weight and vitals, administer study drug. Some visits will have blood and urine tests.

Visits 16-21 (1-2 hours)

  • Follow up visit onsite, Review medical history and current medications, height, weight and vitals, blood and urine tests.

Participants will be compensated for all visits. 

Leader
Steven M. Willi, MD

Steven M. Willi, MD