For Healthcare Professionals

At-Risk for Type 1 Diabetes Extension Study

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About the study

This study is 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 develop clinical type 1 diabetes after the conclusion of that trial, are 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

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

EXCLUSION CRITERIA

  1. Has an active infection and/or fever.
  2. Has 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 has 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.
Phone iconCall 908-356-0514Email iconEmail Study Center

Study’s details


Contition

Diabetes Mellitus, Type 1

Age

0+

Phase

Phase 2

Participants needed

30

Est. Completion Date

Aug 2024

Treatment type

Interventional


Sponsor

Provention Bio, Inc.

ClinicalTrials.gov identifier

NCT04270942

Study number

PRV-031-002

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