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Be Part of Research - Trial Details - Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab

Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab

Completed

Open to: ALL

Age: 8.0 - 17.0

Medical Conditions

Diabetes Mellitus
Diabetes Mellitus, Type 1


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Apr 2019 May 2023

Publications

"Ramos EL, Dayan CM, Chatenoud L, Sumnik Z, Simmons KM, Szypowska A, Gitelman SE, Knecht LA, Niemoeller E, Tian W, Herold KC; PROTECT Study Investigators. Teplizumab and beta-Cell Function in Newly Diagnosed Type 1 Diabetes. N Engl J Med. 2023 Dec 7;389(23):2151-2161. doi: 10.1056/NEJMoa2308743. Epub 2023 Oct 18."; "37861217"

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : Treatment

Intervention Arm Group : Teplizumab;

Intervention Type : BIOLOGICAL
Intervention Description : Control

Intervention Arm Group : Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Northwick Park Hospital - Paediatrics (site 904)
    London
    City Of London
    HA1 3UJ
  • Cardiff and Vale NHS Trust - University Hospital of Wales (Site 902)
    Cardiff
    CF14 4XN
  • Sheffield Children's NHS Foundation Trust Western Bank (Site 903)
    Sheffield
    s10 2TH


The study is sponsored by Provention Bio, Inc.





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Read full details for Trial ID: NCT03875729
Last updated 27 March 2024

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