Relatives of People with Diabetes: Age 8 to 45 Years With an Abnormal OGTT and Positive for 2 Antibodies
DRUG NAME: TEPLIZUMAB
Study Name: Anti-CD3 mAb (Teplizumab) for Prevention of Diabetes in Relatives At-Risk for Type 1 Diabetes Mellitus
Study Sponsors: TrialNet
Principal Investigator: Stephen E. Gitelman, MD, Director of the Pediatric Diabetes Program at UCSF
Who can sign up for this study? Volunteers must be a relative of someone with type 1 diabetes and be between 8 and 45 years old and have had an abnormal OGTT in the past 6 months and be positive for two autoantibodies. Volunteers must weigh at least 57.2 pounds.
In addition, volunteers cannot have any of the following conditions:
-No infectious mononucleosis-like illness within the last 3 months prior to enrollment
-No untreated hypothyroidism or active Graves’ disease
-No concurrent autoimmune disease
-No concurrent use of steroids
-No active infection
-No vaccination with a live virus within the past 8 weeks or a vaccination with a killed virus within 4 weeks.
What is this study about? The UCSF Pediatric Clinical Research Program is conducting a study on an investigational (not approved by the FDA) medication, teplizumab, to see if it will stop the destruction of the insulin making cells in people at-risk of developing diabetes.
What will happen in this study? Volunteers who qualify and are enrolled will receive one 14-day treatment of either the study drug or a placebo. All volunteers will be monitored for 6 years to assess their overall health and to perform laboratory testing to determine the effects of the treatment to their immune system and beta cells. This will require several visits to UCSF for laboratory testing during this period.
How long will this study last? Each volunteer will be followed for up to 6 years.
Reimbursement: You will not be charged for any of the study treatments and may be eligible for reimbursement for your time, effort and travel expenses.
For more information: Please contact Kathleen Fraser at 415-353-9084 or email email@example.com.