Stopped: Study terminated early due to low enrollment and lack of feasibility to meet target enrollment.
United States2 participantsStarted 2023-11-01
Plain-language summary
A multi-center, placebo-controlled, double blind, 2:1 randomized control clinical trial testing low-dose ATG vs. placebo in subjects with a 2 year 50% risk of progression to stage 3 T1D. This study did not meet enrollment targets and was terminated approximately 13 months after the first participant enrolled.
Who can participate
Age range6 Years – 34 Years
SexALL
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Inclusion criteria
✓. Willing to provide informed consent or have a parent or legal guardian provide informed consent when the subject is \<18 years of age.
✓. Age greater than or equal to 6 and \< 35 years
✓. At least two or more diabetes-related biochemical autoantibodies (mIAA, GADA, ICA, IA-2A, ZnT8A) present on the same sample. In the absence of other antibodies, ICA and GADA positivity alone will not suffice for eligibility in this trial.
✓. Weight greater than the 5th percentile for age and sex.
✓. BMI \< 95th and \> 5th percentile for age for those under age 18 years and \< 30 and \> 15 for adults (≥ 18)
✓. ADA Stage 2 criteria\* AND at least one of the following high-risk markers (occurring at the same visit) within 7 weeks (52 days) of randomization, defined below (for defining a 2-year 50% risk for progression to Stage 3 T1D):
✓. CMV and/or EBV seronegative participants must be CMV and EBV PCR negative within 30 days of randomization and may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days of randomization.
✓. CMV seropositive participants must be CMV PCR negative and all EBV seropositive participants must have EBV PCR \< 2,000 IU/mL within 30 days of randomization and may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days of randomization.