Description of Patients With Type 1 Diabetes Treated With Teplizumab
NCT ID: NCT06892002
Last Updated: 2025-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
110 participants
OBSERVATIONAL
2025-02-11
2025-08-05
Brief Summary
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Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Teplizumab treated participants
Participants who received teplizumab as part of their routine clinical care
Teplizumab
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Interventions
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Teplizumab
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Eligibility Criteria
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Inclusion Criteria
* Patient received ≥ 1 day of teplizumab treatment.
Exclusion Criteria
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
University of California, San Francisco
San Francisco, California, United States
Barbara Davis Center For Childhood Diabetes
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Miami Medical Center
Miami, Florida, United States
USF Diabetes Center
Tampa, Florida, United States
Doctor's Clinic
Vero Beach, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Childrens Healthcare of Atlanta
Atlanta, Georgia, United States
Riley Hospital for Children
Carmel, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Boston Children's Hospital Division of Endocrinology
Boston, Massachusetts, United States
Atlantic Health
Morristown, New Jersey, United States
Hassenfeld Children's Hospital at NYU Langone
New York, New York, United States
Morgan Stanley Children's Hospital
New York, New York, United States
Ten's Medical PC
Staten Island, New York, United States
SUNY Upstate Medical University PARENT
Syracuse, New York, United States
Sanford Research/USD
Fargo, North Dakota, United States
AM Diabetes & Endocrinology Center
Bartlett, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
El Paso Medical Research Institute
El Paso, Texas, United States
University of Utah Hospitals & Clinics
Salt Lake City, Utah, United States
Diabetes and Endocrine Treatment Specialists
Sandy City, Utah, United States
Schneider Children's Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Other Identifiers
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U1111-1315-4417
Identifier Type: REGISTRY
Identifier Source: secondary_id
PDE0109
Identifier Type: -
Identifier Source: org_study_id
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