Clinical Study Details
Title | Anti-CD3 mAb (Teplizumab) for Prevention Of Diabetes In Relatives At Risk For Type 1 Diabetes Mellitus |
Description | A study is being done to see if Anti-CD3 mAb (Teplizumab) can delay or prevent the onset of type 1 diabetes in individuals identified as being at high risk for developing the disease. |
Eligibility | You (or your child) are eligible to be screened in the TrialNet Natural History to determine your risk of developing type 1 diabetes if you (or your child) are a first degree blood relative (sibling, child, or parent) between the ages of 3 and 45 years or a second degree relative (cousin, uncle, aunt, niece, nephew, grandparent, or half-sibling) between 3 and 20 years of age. The pathway to this study is through the Natural History study. |
Procedures | If you are in this study, you may have to stay near a study site that is not close to your home for the first 14 days of the study. At the first 14 treatment visits, you will get study IV infusions: either teplizumab or placebo, which will determined by chance.. Neither you nor your study team will know which you are getting. You will need to come for 5 more study visits in the first year, and every 6 months after the first year to undergo assessments of their insulin production, immunologic status, overall health and well-being The screening, treatment, and follow-up visits might be done at different Clinical Centers. |
Contact | If you are interested in having either you or your child screened for the Natural History Study and potential eligibility for this study, please contact Trudy Esrey, 650-498-4450, tesrey@stanford.edu to discuss any questions you may have and to schedule a screening appointment. Please visit the TrialNet public website at http://www.diabetestrialnet.org |
Please review the consent form, as well as the TrialNet public website, for more information.
- Screening Consent Form
- Intervention Consent Form
- Follow Up Consent Form
- Screening Assent Form for Ages 8-11
- Screening Assent Form for Ages 12-17
- Intervention Assent Form for Ages 8-11
- Intervention Assent Form for Ages 12-17
- Follow Up Assent Form for Ages 8-11
- Follow Up Assent Form for Ages 12-17
- TrialNet public website at http://www.diabetestrialnet.org