Logo 1 Logo 2

Clinical Trial Details

Trial ID: L5148
Source ID: NCT04291703
Associated Drug: Antithymocyte Globulin
Title: STOP-T1D Low-Dose (ATG)
Acronym: TN28
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: Antithymocyte Globulin|DRUG: Placebo (for ATG)
Outcome Measures: Primary: Progression to Stage 3 T1D, The primary outcome is the elapsed time from random treatment assignment to the development of diabetes or time of last contact among those randomized, 5 years |
Sponsor/Collaborators: Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE2
Enrollment: 101
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2023-11-01
Completion Date: 2029-12-31
Results First Posted:
Last Update Posted: 2024-10-17
Locations: Children's Hospital of Orange County, Orange, California, 92868, United States|University of California - San Francisco, San Francisco, California, 94143, United States|Stanford University, Stanford, California, 94305, United States|Barbara Davis Center at University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States|Yale University School of Medicine, New Haven, Connecticut, 06511, United States|University of Florida, Gainesville, Florida, 32610, United States|University of Miami, Miami, Florida, 33136, United States|University of South Florida Diabetes Center, Tampa, Florida, 33612, United States|Emory Children's Center, Atlanta, Georgia, 30322, United States|Indiana University - Riley Hospital for Children, Indianapolis, Indiana, 46202, United States|Children's Hospital of Iowa, Iowa City, Iowa, 52242, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|The Children's Mercy Hospital, Kansas City, Missouri, 64108, United States|Columbia University-Naomi Berrie Diabetes Center, New York, New York, 10032, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States|Prisma Health, Greenville, South Carolina, 29615, United States|Vanderbilt Eskind Diabetes Center, Nashville, Tennessee, 37232, United States|University of Texas Southwestern Medical Center, Dallas, Texas, 75390, United States|University of Utah, Salt Lake City, Utah, 84132, United States|Benaroya Research Institute, Seattle, Washington, 98101, United States|Queensland Children's Hospital, South Brisbane, Queensland, 4101, Australia|Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, 3050, Australia
URL: https://clinicaltrials.gov/show/NCT04291703