Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)
NCT ID: NCT04598893
Last Updated: 2025-12-09
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
188 participants
OBSERVATIONAL
2020-10-26
2026-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
NCT00920582
At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension)
NCT04270942
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab
NCT03875729
Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk"
NCT01030861
Teplizumab in Pediatric Stage 2 Type 1 Diabetes
NCT05757713
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants who complete the PROTECT study are invited to enroll in this observational, extension study to collect long-term safety and other clinical data. The decision to participate can be made within 12 months of completing the PROTECT study.
No study drug will be administered during this extension study. Participants will continue to receive standard care for type 1 diabetes from their primary physicians.
Participants will return to the study sites for assessments once every 6 months through Month 42. Therefore, the combined duration of the PROTECT and PROTECT Extension studies will be 60 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Teplizumab
Participants who received teplizumab in the PROTECT study
Teplizumab
Received teplizumab in PROTECT Study
Placebo
Participants who received placebo in the PROTECT study
Placebo
Received placebo in PROTECT study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Teplizumab
Received teplizumab in PROTECT Study
Placebo
Received placebo in PROTECT study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Provide written informed consent within 12 months of the Week 78 in the PRV-031-001 study. Written assent will be obtained for participants under 18 years of age at the time of enrollment, according to applicable regulations. If possible, written informed consent and/or assent for the current PROTECT Extension study (PRV-031-003) should be obtained at the final (Week 78) visit in the PROTECT study.
Exclusion Criteria
9 Years
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Provention Bio, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rady Children's Hospital 3020 Children's Way (Site 840004)
San Diego, California, United States
UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001)
San Francisco, California, United States
Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002)
Walnut Creek, California, United States
Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005)
Aurora, Colorado, United States
Nemours Children's Health, 807 Children's Way
Jacksonville, Florida, United States
Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048)
St. Petersburg, Florida, United States
Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009)
Atlanta, Georgia, United States
Centricity Research (Site 840006)
Columbus, Georgia, United States
St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052)
Boise, Idaho, United States
Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007)
Idaho Falls, Idaho, United States
Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014)
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023)
Iowa City, Iowa, United States
Capital Medical Research Associates (Site 840029)
Camp Springs, Maryland, United States
Baystate Medical Center, 759 Chestnut Street
Springfield, Massachusetts, United States
Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026)
Kansas City, Missouri, United States
Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018)
St Louis, Missouri, United States
UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010)
Buffalo, New York, United States
UNC Hospitals, The University of North Carolina at Chapel Hill, Children's Specialty Clinic, 101 Manning Drive (Site 840038)
Chapel Hill, North Carolina, United States
Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034)
Bend, Oregon, United States
Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021)
Philadelphia, Pennsylvania, United States
AM Diabetes & Endocrinology Center, 3025 Kate Bond Rd. (Site 840008)
Bartlett, Tennessee, United States
Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024)
Nashville, Tennessee, United States
UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033)
Dallas, Texas, United States
Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016)
Seattle, Washington, United States
MultiCare Health System, Gateway Medical Building (Site 840003)
Tacoma, Washington, United States
University Hospital Brussels (Site 056202)
Jette, Brussels Capital, Belgium
UCL Namur University Hospital Place Louise Godin 15 (Site 056205)
Namur, Namur, Belgium
Alberta Diabetes Institute, 2-004 Li Ka Shing Centre for Health Research Innovation 8602 (Site 124103)
Edmundston, Alberta, Canada
BCDiabetes - Medical Research Center, 210 West Broadway Suite 400 (Site 124102)
Vancouver, British Columbia, Canada
University Hospital Motol V Uvalu 84, Praha 5 - Motol (Site 203301)
Prague, , Czechia
Hospital Center Regional D'Orleans Hospital La Source, Pediatric Department, 14 Hospital Ave Post box 86709 (Site 250513)
Orléans, France, France
Woman Mother Child Hospital HCL
Bron, , France
Dijon University Hospital Center-Francois Mitterand Hospital, Children's Hospital
Dijon, , France
CHU La Timone - La Timone Children's Hospital
Marseille, , France
Lenval Hospital, 57 Avenue de la Californie (Site 250508)
Nice, , France
Necker Children's Hospital, 149 Rue de Sevres (Site 250502)
Paris, , France
Pau Hospital Center
Pau, , France
Evangelic Clinic Bethel, Children's Clinic Grenzweg 14/Hs 2 (Site 276602)
Bethel, Bielefeld, Germany
Hospital Augsburg, Stenglinstrasse 2 (Site 276606)
Augsburg, , Germany
University Hospital Carl Gustav Carus Fetscherstrasse 74 (Site 276601)
Dresden, , Germany
Pediatric Hospital on the Bult Janusz-Korczak-Allee 12 (Site 276604)
Hanover, , Germany
University Hospital Heidelberg, Im Neuenheimer Feld 430 (Site 276608)
Heidelberg, , Germany
University Teaching Centre of the Medical University of Warsaw, 63A, ul. Zwirki i Wigur (Site 616804)
Warsaw, Poland, Poland
University Teaching Centre, Department of Pediatrics, Diabetology and Endocrinology (Site 616803)
Gdansk, , Poland
Institute of Diabetology ul. Raclawicka 129/2U, 02-117 (Site 616802)
Warsaw, , Poland
Children's Memorial Health Institute Al. Dzieci Polskich 20 (Site 616801)
Warsaw, , Poland
Sheffield Children's Hospital Western Bank, S10 2TH (Site 826903)
Sheffield, Yorkshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRV-031-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.