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Teplizumab in Pediatric Stage 2 Type 1 Diabetes
Sponsor: Sanofi
Summary
The purpose of this study is to assess the safety and pharmacokinetics (PK) of teplizumab in participants with Stage 2 type 1 diabetes who are \<8 years of age.
Official title: Single Arm, Open-label Study to Assess the Safety and Pharmacokinetics of a 14-day Regimen of Teplizumab in Pediatric Stage 2 Type 1 Diabetes (Participants <8 Years of Age With at Least Two Autoantibodies and Dysglycemia)
Key Details
Gender
All
Age Range
0 Years - 7 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2023-07-25
Completion Date
2026-08-27
Last Updated
2026-01-30
Healthy Volunteers
No
Conditions
Interventions
teplizumab
CD3-directed humanized monoclonal antibody
Locations (10)
UCSF Medical Center Site Number : 107
San Francisco, California, United States
Barbara Davis Center for Diabetes Site Number : 102
Aurora, Colorado, United States
Yale University School of Medicine Site Number : 101
New Haven, Connecticut, United States
Centricity Research Site Number : 104
Columbus, Georgia, United States
Indianapolis University Health Riley Hospital for Children Site Number : 110
Indianapolis, Indiana, United States
UBMD Pediactrics Site Number : 105
Buffalo, New York, United States
Children's Hospital of Philadelphia Site Number : 108
Philadelphia, Pennsylvania, United States
Sanford Diabetes and Thyroid Clinic Site Number : 106
Sioux Falls, South Dakota, United States
Vanderbilt Univerity Medical Center Site Number : 109
Nashville, Tennessee, United States
MulitCare Institute for Research & Innovation Site Number : 103
Tacoma, Washington, United States