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NCT05757713
Teplizumab in Pediatric Stage 2 Type 1 Diabetes
Conditions: Type 1 Diabetes
Sex: All
Ages: 0 Years – 7 Years
Phase: PHASE4
Enrollment: 20
Sponsor: Provention Bio, Inc.
Summary
The purpose of this study is to assess the safety and PK of teplizumab in participants with Stage 2 type 1 diabetes who are <8 years of age.
Eligibility Criteria
Inclusion Criteria:Participant is a male or female 0 to < 8 years of age, inclusive, at Day 1Participant has Stage 2 T1D (two T1D-related autoantibodies and dysglycemia)Exclusion Criteria:Participant has any autoimmune disease other than T1D with the exception of stable thyroid or celiac diseaseHas an active infection and/or feverHas 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).Has any condition that, in the opinion of the Investigator, would interfere with the study conduct or the safety of the participant.
Source: ClinicalTrials.gov (NCT05757713). StuddyBuddy aggregates publicly available trial information.