Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes (NCT03929601) | Clinical Trial Compass
Active ā Not RecruitingPhase 2
Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes
United States74 participantsStarted 2023-10-30
Plain-language summary
The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D. The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with Abatacept after Rituximab-pvvr compared to those treated with Rituximab-pvvr and placebo 24 months after enrollment.
Who can participate
Age range8 Years ā 45 Years
SexALL
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Inclusion criteria
ā. Age ā„ 8 and ā¤ 45 years old at time of signing informed consent.
ā. Fulfill the ADA criteria for diagnosis of T1D within 100 days of randomization.
ā. Must be willing to provide informed consent or assent with a parent or legal guardian providing informed consent if \< 18 years of age.
ā. Positive for at least one islet cell autoantibody; GAD65A, mIAA (if obtained within 10 days of the onset of insulin therapy), IA-2A, ICA, or ZnT8A
ā. Must have stimulated C-peptide of ā„0.2 pmol/mL measured during mixed-meal tolerance test (MMTT) conducted at least 21 days after the diagnosis of diabetes.
ā. Enrollees must be willing to comply with intensive diabetes management.
ā. Body weight must be ā„ 20.0 kg for study agent administration.
ā. Subjects who are CMV and/or EBV seronegative at screening must be CMV and/or EBV PCR negative and may not have had signs or symptoms of a CMV and/or EBV compatible illness prior to randomization.
Exclusion criteria
ā. One or more screening laboratory values as stated:
ā. Leukocytes \<3,000/Ī¼L
ā. Neutrophils \<1,500/Ī¼L
ā. Lymphocytes \<800/Ī¼L
What they're measuring
1
C-Peptide Response to 2-hr MMTT at 24 months post-randomization
Timeframe: 48-months from Day 0
Trial details
NCT IDNCT03929601
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)