Frequently Asked Questions
- What is the AbATE Trial?
- Where is the AbATE study taking place?
- How many people will be participating?
- Am I/Is my child eligible to participate?
- What is the study drug?
- Do all participants receive hOKT3γ1(Ala-Ala)?
- Will I or my doctor know if I am receiving the drug or not?
- How is hOKT3γ1(Ala-Ala) administered?
- How many treatments are required?
- Will I/my child be hospitalized during treatment?
- Are there any potential side effects to hOKT3γ1(Ala-Ala)?
- Who are the key personnel involved in the study?
- Who is sponsoring the study?
- Where can I get more information?
---- What is the AbATE Trial?
The AbATE Type 1 Diabetes study is a clinical trial testing a new antibody therapy known as hOKT3γ1(Ala-Ala) to determine whether it can halt the progression of type 1 diabetes by establishing a state of immune "tolerance" towards the beta cells. Where is the AbATE study taking place?
The study is taking place at several clinical centers in the US. An up-to-date list of clinical centers may be found here.
How many participants are needed?
The study will enroll a total of 81 participants overall.
Am I/Is my child eligible to participate?
If you or your child are between the ages 8-30 and have been diagnosed with type 1 diabetes within the past 6 weeks, you may be eligible to participate.
What is the study drug?
hOKT3g1(Ala-Ala) is a monoclonal antibody designed to interfere with the activation of immune cells that attack the insulin-producing beta cells of the pancreas. In previous, preliminary studies, a 2-week therapy with the drug resulted in a preservation of beta cell function for up to two years in newly diagnosed type 1 diabetes patients.
Do all participants receive hOKT3γ1(Ala-Ala)?
No. This is a randomized study, meaning that participants will be randomly selected to receive either the study drug (treatment group) or standard diabetes management (control group). For every 1 individual assigned to the control group, 2 will be assigned to the treatment group to receive the drug.
Will I or my doctor know if I am receiving the drug or not?
Yes. This study is "open-label," meaning that both participant and physician know what treatment is being used.
How is hOKT3γ1(Ala-Ala) administered?
hOKT3γ1 will be given through an IV catheter – a thin, plastic tube that is placed into the vein of your (child’s) arm. This procedure is called an infusion and the process takes about 15-30 minutes.
How many treatments are required?
If you/your child are randomly selected to receive the study drug, you/your child will receive two treatment cycles with hOKT3γ1(Ala-Ala), scheduled one year apart. Each treatment cycle consists of one infusion of hOKT3γ1(Ala-Ala) every day for 14 days.
Will I/my child be hospitalized during treatment?
If you/your child are randomly selected to receive the study drug, you will be required to stay in the hospital for at least 5 - 7 days for each of the two treatment sessions. If you live within an hour of the hospital, the remaining 7-9 days of treatment for each of the two sessions may completed on an outpatient basis, however you will need to remain at the hospital for 6 hours after treatment.
Are there any potential side effects to hOKT3γ1(Ala-Ala)?
All medications have the potential for side effects. It is important to note that experimental treatments, like this one, may have both known and unknown potential side effects. Known side effects of hOKT3γ1(Ala-Ala) include headache, fever, chills, and muscle and/or joint pain when you first get the drug; a temporary rash near the injection site; and tiredness, due to a lowered red blood cell count. Not all side effects have occurred in all patients receiving the drug.
Who are the key personnel involved in the study?
The Principal Investigator and Study Chair is Dr. Kevan Herold, MD of Columbia University in New York. Dr. Herold also led previous clinical studies with hOKT3γ1(Ala-Ala) in type 1 diabetes. Dr. Jeffrey Bluestone, Director of the Diabetes Center at UCSF, who developed hOKT3γ1(Ala-Ala) is a co-investigator of the study.
Who is sponsoring the study?
The study is being conducted by the Immune Tolerance Network, an international consortium of researchers studying new "tolerance" therapies for autoimmune diseases, organ transplantation and asthma and allergic conditions. The ITN receives its funding from the National Institute of Allergy and Infectious Diseases, the National Institute for Diabetes, Digestive and Kidney Diseases and the Juvenile Diabetes Research Foundation. The study is sponsored by the National Institute for Allergy and Infectious Diseases.
Where can I get more information?
For more information on the study, contact the study coordinator at the clinical site nearest you.
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