| Trial ID: | L4422 |
| Source ID: | NCT06455319
|
| Associated Drug: |
Anti-Thymocyte Globulin (Atg)
|
| Title: |
Precision Administration of Anti-thymocyte Globulin With or Without Verapamil
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Anti-thymocyte globulin (ATG)|DRUG: verapamil extended release capsule|DRUG: Placebo
|
| Outcome Measures: |
Primary: AUC C-peptide between ATG and placebo values, mean difference between ATG and placebo values of the 2-hr mixed meal tolerance test (MMTT)-stimulated area under the curve (AUC) C-peptide at 12 months, 12 Months|Change in 2-hr MMTT AUC C-peptide, mean difference between the change in 2-hr MMTT stimulated AUC C-peptide, 6 months | Secondary: Immune and beta cell mechanistic analyses, To explore mechanisms of synergy between ATG received in year 1 and the addition of open-label verapamil in year 2., 6, 12, 18, 24 months
|
| Sponsor/Collaborators: |
Sponsor: University of Florida | Collaborators: University of Colorado, Denver|University of Miami
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2025-04
|
| Completion Date: |
2030-04
|
| Results First Posted: |
|
| Last Update Posted: |
2024-10-18
|
| Locations: |
University of Florida, Gainesville, Florida, 32610, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06455319
|
