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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05757713). StuddyBuddy aggregates publicly available trial information.