Type 1 Diabetes (T1D) Clinical Trials

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An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes

Status: Recruiting
Location: See all (37) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Stage 2 Type 1 Diabates (T1D) is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms. Progression of the disease to Stage 3 (clinical T1D), leads to overt hyperglycemia requiring eventually exogenous insulin. 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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

⁃ TZIELD-Exposed Cohort

• 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

• 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

Locations
United States
California
University of California Los Angeles Health- Site Number : 8400020
RECRUITING
Los Angeles
University of California San Francisco - Mission Bay- Site Number : 8400005
RECRUITING
San Francisco
Colorado
University of Colorado Hospital- Site Number : 8400026
RECRUITING
Aurora
Connecticut
Yale University School of Medicine- Site Number : 8400025
RECRUITING
New Haven
Florida
University of Florida Health- Site Number : 8400035
RECRUITING
Gainesville
Nemours Children's Speciality Care- Jacksonville- Site Number : 8400006
RECRUITING
Jacksonville
Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400034
RECRUITING
Miami
University of Miami Miller School of Medicine- Site Number : 8400037
RECRUITING
Miami
University of South Florida- Site Number : 8400022
RECRUITING
Tampa
Georgia
Midtown Medical Center - Columbus- Site Number : 8400013
RECRUITING
Columbus
Illinois
University of Chicago Medical Center- Site Number : 8400017
RECRUITING
Chicago
Indiana
Indiana University Health Riley Hospital for Children- Site Number : 8400004
RECRUITING
Indianapolis
Kentucky
Norton Brownsboro Hospital- Site Number : 8400030
RECRUITING
Louisville
Maryland
Johns Hopkins School of Medicine- Site Number : 8400031
RECRUITING
Baltimore
Michigan
University of Michigan Health System - Ann Arbor- Site Number : 8400028
RECRUITING
Ann Arbor
Associated Endocrinologists, PC- Site Number : 8400039
RECRUITING
Farmington Hills
Corewell Health - Grand Rapids - Michigan Street Northeast- Site Number : 8400009
RECRUITING
Grand Rapids
Minnesota
Mayo Clinic- Site Number : 8400010
RECRUITING
Rochester
Missouri
Children's Mercy Adelle Hall Campus- Site Number : 8400014
RECRUITING
Kansas City
North Carolina
UNC Children's Hospital- Site Number : 8400008
RECRUITING
Chapel Hill
New York
Women & Children's Hospital of Buffalo- Site Number : 8400018
RECRUITING
Buffalo
Feinstein Institute for Medical Research (Northwell)- Site Number : 8400016
RECRUITING
Manhasset
Ten's Medical PC- Site Number : 8400027
RECRUITING
Staten Island
SUNY Upstate Medical University - Syracuse- Site Number : 8400007
RECRUITING
Syracuse
Ohio
Cincinnati Children's Hospital Medical Center- Site Number : 8400024
RECRUITING
Cincinnati
Rainbow Babies And Children's Hospital- Site Number : 8400011
RECRUITING
Cleveland
The Ohio State University- Site Number : 8400032
RECRUITING
Columbus
Pennsylvania
Hospital of The University of Pennsylvania- Site Number : 8400021
RECRUITING
Philadelphia
The Children's Hospital of Philadelphia- Site Number : 8400029
RECRUITING
Philadelphia
Tennessee
AM Diabetes & Endocrinology Center- Site Number : 8400012
RECRUITING
Bartlett
Vanderbilt University Medical Center- Site Number : 8400023
RECRUITING
Nashville
Texas
Texas Diabetes & Endocrinology - Austin - North Mopac Expressway- Site Number : 8400040
RECRUITING
Austin
University of Texas - Southwestern Medical Center- Site Number : 8400003
RECRUITING
Dallas
Cook Children's- Site Number : 8400038
RECRUITING
Fort Worth
Texas Children's Hospital- Site Number : 8400002
RECRUITING
Houston
Utah
University of Utah Health Hospital- Site Number : 8400019
RECRUITING
Salt Lake City
West Virginia
United BioSource Corporation- Site Number : 8400001
RECRUITING
Morgantown
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-09-27
Estimated Completion Date: 2037-01-15
Participants
Target number of participants: 200
Treatments
TZIELD group
Patients prior to the initiation of TZIELD treatment or initiated TZIELD treatment within 6 months to study enrollment
Comparator group
Patients not planned to be treated
Related Therapeutic Areas
Type 1 Diabetes (T1D)
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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