At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Previous participant in the TN-10 study
  2. 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).
  3. Participant was able to initiate teplizumab treatment required in this study within 1 year of type 1 diabetes diagnosis.
  4. Participant was willing to forego other forms of experimental treatment during the entire study.
  5. Participant and/or guardian had given informed consent and assent as applicable.

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Had an active infection and/or fever.
  2. 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).
  3. 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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

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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