Status:
COMPLETED
At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)
Lead Sponsor:
Provention Bio, a Sanofi Company
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
The study was a single-arm, multicenter, open-label clinical trial. All participants received a 12-day course of teplizumab given through daily IV infusion and were followed for 78 weeks. The purpose...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04270942
Start Date
February 26 2020
End Date
January 22 2024
Last Update
February 12 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Barbara Davis Center for Diabetes Site Number : 04
Aurora, Colorado, United States, 80045
2
Clinical Site
Aurora, Colorado, United States, 80045
3
Yale University School of Medicine Site Number : 01
New Haven, Connecticut, United States, 06511
4
Clinical Site
New Haven, Connecticut, United States, 06519