EICHORCondition: Type 1 Diabetes Mellitus · Sponsor: Provention Bio, Inc.
Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.
The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.. Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: 1. Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study drug administration. 2. Has received a diagnosis of type 1 diabetes (T1D) according to the criteria from the American Diabetes Association. 3. Is able to be randomized and initiate study drug within 6 weeks (42 days) of the formal T1D diagnosis. 4. Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test (MMTT) at screening. 5. Has a positive result on testing for T1D-related autoantibodies. Exclusion Criteria: 1. 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. An individual who has a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Rady Children's Hospital-San Diego (Site 004) | San Diego, California, United States | — |
| UCSF Medical Center (Site 001) | San Francisco, California, United States | — |
| Diablo Clinical Research, Inc. (Site 002) | Walnut Creek, California, United States | — |
| University of Colorado-Barbara Davis Center for Childhood Diabetes (Site 005) | Aurora, Colorado, United States | — |
| Yale University of Medicine (Site 020) | New Haven, Connecticut, United States | — |
| UF Clinical and Translation Research Building (Site 015) | Gainesville, Florida, United States | — |
| Nemours Children's Specialty Care-Endocrinology (Site 047) | Jacksonville, Florida, United States | — |
| University of Miami Health System (Site 028) | Miami, Florida, United States | — |
| All Children's Hospital-Johns Hopkins Medicine (Site 048) | St. Petersburg, Florida, United States | — |
| University of South Florida Diabetes and Endocrinology Center (Site 011) | Tampa, Florida, United States | — |
| Atlanta Diabetes Associates (Site 009) | Atlanta, Georgia, United States | — |
| Centricity Research (Site 006) | Columbus, Georgia, United States | — |
+ 50 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT03875729