At-Risk for Type 1 Diabetes Extension Study
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.
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 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).
- Participant is able to initiate teplizumab treatment required in this study within 1 year of type 1 diabetes diagnosis.
- Participant is willing to forego other forms of experimental treatment during the entire study.
- Participant and/or guardian has given informed consent and assent as applicable.
EXCLUSION CRITERIA
Exclusion Criteria:
- Has an active infection and/or fever.
- 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).
- 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.
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’s details
Contition
Diabetes Mellitus, Type 1
Phase
Phase 2
Participants needed
30
Est. Completion Date
Aug 31, 2024
Treatment type
Interventional
Sponsor
Provention Bio, Inc.
ClinicalTrials.gov identifier
NCT04270942
Study number
PRV-031-002
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?