NCT04270942CompletedPhase 2
At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)
An Open-Label Study to Evaluate the Safety of Teplizumab (PRV-031) in At-Risk Relatives Who Develop Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 12 Feb 2025
Brief summary (registry, in English)
This study was an extension of the NIH-sponsored At-Risk (TN-10) type 1 diabetes study (NCT 01030861). Teplizumab-treated and placebo-treated participants in the NIH trial who developed clinical type 1 diabetes after the conclusion of that trial, were eligible to enroll and receive teplizumab treatment within one year of diagnosis of clinical type 1 diabetes.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 10 Feb 2020
- Start date
- 26 Feb 2020
- Primary completion date
- 22 Jan 2024
- Lead sponsor
- Provention Bio, a Sanofi Company
- Diseases
- Type 1 diabetes
- NCT number
- NCT04270942
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 6
- From 26 Feb 2020 to the primary completion date, 22 Jan 2024
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Had an active infection and/or fever.
- Had 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).
- An individual who had a medical, psychological or social condition that, in the opinion of the Principal Investigator, would interfere with safe and proper completion of the trial.
Who the study is looking for
- Previous participant in the TN-10 study
- Participant had received a diagnosis of type 1 diabetes after the conclusion of the TN-10 study, according to the criteria from the American Diabetes Association (ADA).
- Participant was able to initiate teplizumab treatment required in this study within 1 year of type 1 diabetes diagnosis.
- Participant was willing to forego other forms of experimental treatment during the entire study.
- Participant and/or guardian had given informed consent and assent as applicable.
Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barbara Davis Center for Diabetes Site Number : 04 Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Florida Site Number : 02 Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Vanderbilt Univerity Medical Center Site Number : 03 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Yale University School of Medicine Site Number : 01 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.