Teplizumab for Pediatric Type 1 Diabetes (PETITE-T1D Trial)

Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Provention Bio, a Sanofi Company

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests the safety of teplizumab, an IV medication, in children under 8 with early signs of type 1 diabetes. The drug aims to protect insulin-producing cells from immune system attacks and has shown potential in delaying the onset of type 1 diabetes.

Eligibility Criteria

This trial is for children under 8 years old with Stage 2 Type 1 Diabetes, which means they have certain diabetes-related antibodies and blood sugar issues. Kids can't join if they have other autoimmune diseases (except stable thyroid or celiac), infections like HIV/HBV/HCV, or any condition that might affect the study or their safety.

Inclusion Criteria

I am under 8 years old.

I have Stage 2 Type 1 Diabetes with certain autoantibodies and blood sugar issues.

Exclusion Criteria

I currently have an infection or fever.

Treatment Details

The trial is testing teplizumab's safety and how it's processed in the body (pharmacokinetics) in young kids with early-stage Type 1 Diabetes to see if it could help manage their condition.

1Treatment groups

Experimental Treatment

Group I: teplizumab injectionExperimental Treatment1 Intervention

teplizumab injection, sterile solution for intravenous use