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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RECRUITING
200 participants
OBSERVATIONAL
2024-09-27
2037-01-15
Brief Summary
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TZIELD® (teplizumab-mzwv) has been approved to delay onset of stage 3 T1D, by the United States (US) Food and Drug Administration (FDA) for adults and children aged 8 years and older with Stage 2 T1D.
The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD® in patients with Stage 2 T1D, treated as per standard of care.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TZIELD group
Patients prior to the initiation of TZIELD treatment or initiated TZIELD treatment within 6 months to study enrollment
TZIELD (teplizumab-mzwv)
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Comparator group
Patients not planned to be treated
No interventions assigned to this group
Interventions
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TZIELD (teplizumab-mzwv)
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
* Patients in the US diagnosed with Stage 2 T1D who are planned to initiate TZIELD treatment according to the currently approved label or who have initiated TZIELD treatment within 6 months prior to enrollment:
* Day 1: 65 mcg/m2
* Day 2: 125 mcg/m2
* Day 3: 250 mcg/m2
* Day 4: 500 mcg/m2
* Days 5 through 14: 1,030 mcg/m2 per day
* Cumulative dose is approximately 11,240 mcg/m2
* Appropriate written informed consent/assent as applicable for the age of the patient
TZIELD-Unexposed Cohort
* Patients in the US diagnosed with Stage 2 T1D but who are not treated with TZIELD
* Appropriate written informed consent/assent as applicable for the age of the patient
Exclusion Criteria
* Patients who had participated in a previous clinical trial for TZIELD
* Patients in an ongoing clinical trial of an investigational product or who had ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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University of California Los Angeles Health- Site Number : 8400020
Los Angeles, California, United States
University of California San Francisco - Mission Bay- Site Number : 8400005
San Francisco, California, United States
University of Colorado Hospital- Site Number : 8400026
Aurora, Colorado, United States
Yale University School of Medicine- Site Number : 8400025
New Haven, Connecticut, United States
Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006
Jacksonville, Florida, United States
University of Chicago Medical Center- Site Number : 8400017
Chicago, Illinois, United States
Riley Hospital for Children at IU Health- Site Number : 8400004
Indianapolis, Indiana, United States
Norton Healthcare- Site Number : 8400030
Louisville, Kentucky, United States
Johns Hopkins School of Medicine- Site Number : 8400031
Baltimore, Maryland, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400028
Ann Arbor, Michigan, United States
Associated Endocrinologists, PC- Site Number : 8400039
Farmington Hills, Michigan, United States
Corewell Health- Site Number : 8400009
Grand Rapids, Michigan, United States
Mayo Clinic- Site Number : 8400010
Rochester, Minnesota, United States
Children's Mercy Adelle Hall Campus- Site Number : 8400014
Kansas City, Missouri, United States
Women and Children's Hospital of Buffalo- Site Number : 8400018
Buffalo, New York, United States
Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016
Manhasset, New York, United States
Ten's Medical PC- Site Number : 8400027
Staten Island, New York, United States
SUNY Upstate Medical University - Syracuse- Site Number : 8400007
Syracuse, New York, United States
UNC Children's Hospital- Site Number : 8400008
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center- Site Number : 8400024
Cincinnati, Ohio, United States
Rainbow Babies And Children's Hospital- Site Number : 8400011
Cleveland, Ohio, United States
Columbus Regional Healthcare- Site Number : 8400013
Columbus, Ohio, United States
The Ohio State University- Site Number : 8400032
Columbus, Ohio, United States
Hospital of The University of Pennsylvania- Site Number : 8400021
Philadelphia, Pennsylvania, United States
The Children's Hospital of Philadelphia- Site Number : 8400029
Philadelphia, Pennsylvania, United States
AM Diabetes & Endocrinology Center- Site Number : 8400012
Bartlett, Tennessee, United States
Vanderbilt University Medical Center- Site Number : 8400023
Nashville, Tennessee, United States
University of Texas - Southwestern Medical Center- Site Number : 8400003
Dallas, Texas, United States
Texas Children's Hospital- Site Number : 8400002
Houston, Texas, United States
University of Utah Health Care- Site Number : 8400019
Salt Lake City, Utah, United States
United BioSource Corporation- Site Number : 8400001
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Other Identifiers
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U1111-1306-6690
Identifier Type: REGISTRY
Identifier Source: secondary_id
OBS18117
Identifier Type: -
Identifier Source: org_study_id
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