NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Teplizumab in Pediatric Stage 2 Type 1 Diabetes

Active Not RecruitingPhase 4

Sponsor: Sanofi

Conditions: Diabetes Mellitus, Type 1

Interventions: teplizumab

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 0 Years to 7 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Participant is a male or female 0 to \< 8 years of age, inclusive, at Day 1
2. Participant has Stage 2 T1D (two T1D-related autoantibodies and dysglycemia)

Exclusion Criteria:

1. Participant has any autoimmune disease other than T1D with the exception of stable thyroid or celiac disease
2. Has an active infection and/or fever
3. Has 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).
4. Has any condition that, in the opinion of the Investigator, would interfere with the study conduct or the safety of the participant.

Locations (10)

San Francisco, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Columbus, Georgia, United States
Indianapolis, Indiana, United States
Buffalo, New York, United States
Philadelphia, Pennsylvania, United States
Sioux Falls, South Dakota, United States
Nashville, Tennessee, United States
Tacoma, Washington, United States