At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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 CRITERIA
Exclusion Criteria:
- 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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Diabetes Mellitus, Type 1
Phase
PHASE2
Participants Needed
6
Est. Completion Date
Jan 22, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Sanofi
ClinicalTrials.gov NCT Identifier
NCT04270942
Study Number
PRV-031-002
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