Status:
WITHDRAWN
Low-dose IL-2 in Established T1D - The "PROREG" Study
Lead Sponsor:
Jay S. Skyler
Collaborating Sponsors:
Diabetes Research Institute Foundation
University of Florida
Conditions:
Diabetes Mellitus, Type 1
Diabetes
Eligibility:
All Genders
8-21 years
Phase:
PHASE1
PHASE2
Brief Summary
Randomized, controlled, double-blinded, multicenter, phase I/II clinical trial to evaluate the safety of low-dose IL-2 and determine whether low-dose IL-2 therapy for one year, can prevent further los...
Detailed Description
Randomized, controlled, double-blinded, multicenter, phase I/II clinical trial to evaluate the safety of low-dose IL-2 and determine whether low-dose IL-2 therapy for one year, can prevent further los...
Eligibility Criteria
Inclusion
- 8-21 years of age
- T1D, demonstrated by at least one islet autoantibody
- T1D duration 4-12 months at the time of the first dose
- Peak stimulated C-peptide \>0.2 nmol/L during a 4-hour MMTT
Exclusion
- Treatment with oral anti-diabetic agents
- Illnesses that would preclude use of low-dose IL-2
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03243058
Start Date
June 1 2023
End Date
December 1 2028
Last Update
May 22 2024
Active Locations (1)
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1
Diabetes Research Institute, University of Miami Miller School of Medicine
Miami, Florida, United States, 33136