Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)
A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Recent-Onset Type 1 Diabetes Mellitus
1 other identifier
observational
188
8 countries
47
Brief Summary
The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2020
Longer than P75 for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
October 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
December 9, 2025
December 1, 2025
6 years
October 16, 2020
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies
Safety outcome
During 42 months of follow-up
Secondary Outcomes (3)
Area under the time-versus concentration curve (AUC) of C-peptide after a 4-hour (4h) mixed-meal tolerance test (MMTT)
During the 42 months of follow-up
Insulin use (daily average insulin dose in U/kg/day)
During the 42 months of follow-up
HbA1c
During the 42 months of follow-up
Study Arms (2)
Teplizumab
Participants who received teplizumab in the PROTECT study
Placebo
Participants who received placebo in the PROTECT study
Interventions
Eligibility Criteria
Participants who completed the PROTECT (PRV-031-001) study
You may qualify if:
- Completion of the PRV-031-001 (PROTECT) study by completing the Week 78 visit in that study, regardless of how many doses of study drug were administered.
- 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.
You may not qualify if:
- \. Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Rady Children's Hospital 3020 Children's Way (Site 840004)
San Diego, California, 92123, United States
UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001)
San Francisco, California, 94158, United States
Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002)
Walnut Creek, California, 945981, United States
Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005)
Aurora, Colorado, 80045, United States
Nemours Children's Health, 807 Children's Way
Jacksonville, Florida, 32207, United States
Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048)
St. Petersburg, Florida, 33701, United States
Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009)
Atlanta, Georgia, 30318, United States
Centricity Research (Site 840006)
Columbus, Georgia, 31904, United States
St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052)
Boise, Idaho, 83712, United States
Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007)
Idaho Falls, Idaho, 83404, United States
Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014)
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023)
Iowa City, Iowa, 52242, United States
Capital Medical Research Associates (Site 840029)
Camp Springs, Maryland, 20746, United States
Baystate Medical Center, 759 Chestnut Street
Springfield, Massachusetts, 01199, United States
Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026)
Kansas City, Missouri, 64108, United States
Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018)
St Louis, Missouri, 63110, United States
UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010)
Buffalo, New York, 14203, 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, 27514, United States
Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034)
Bend, Oregon, 97702, United States
Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021)
Philadelphia, Pennsylvania, 19104, United States
AM Diabetes & Endocrinology Center, 3025 Kate Bond Rd. (Site 840008)
Bartlett, Tennessee, 38133, United States
Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024)
Nashville, Tennessee, 37212, United States
UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033)
Dallas, Texas, 75235, United States
Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016)
Seattle, Washington, 98101, United States
MultiCare Health System, Gateway Medical Building (Site 840003)
Tacoma, Washington, 98405, United States
University Hospital Brussels (Site 056202)
Jette, Brussels Capital, B-1090, Belgium
UCL Namur University Hospital Place Louise Godin 15 (Site 056205)
Namur, Namur, B-5000, Belgium
Alberta Diabetes Institute, 2-004 Li Ka Shing Centre for Health Research Innovation 8602 (Site 124103)
Edmundston, Alberta, T6G 2E1, Canada
BCDiabetes - Medical Research Center, 210 West Broadway Suite 400 (Site 124102)
Vancouver, British Columbia, V5Y 3W2, Canada
University Hospital Motol V Uvalu 84, Praha 5 - Motol (Site 203301)
Prague, 150 06, Czechia
Hospital Center Regional D'Orleans Hospital La Source, Pediatric Department, 14 Hospital Ave Post box 86709 (Site 250513)
Orléans, France, 45067, France
Woman Mother Child Hospital HCL
Bron, 69677, France
Dijon University Hospital Center-Francois Mitterand Hospital, Children's Hospital
Dijon, 21079, France
CHU La Timone - La Timone Children's Hospital
Marseille, 13385, France
Lenval Hospital, 57 Avenue de la Californie (Site 250508)
Nice, 06200, France
Necker Children's Hospital, 149 Rue de Sevres (Site 250502)
Paris, 75015, France
Pau Hospital Center
Pau, 64046, France
Evangelic Clinic Bethel, Children's Clinic Grenzweg 14/Hs 2 (Site 276602)
Bethel, Bielefeld, 33617, Germany
Hospital Augsburg, Stenglinstrasse 2 (Site 276606)
Augsburg, 86156, Germany
University Hospital Carl Gustav Carus Fetscherstrasse 74 (Site 276601)
Dresden, 01307, Germany
Pediatric Hospital on the Bult Janusz-Korczak-Allee 12 (Site 276604)
Hanover, 30173, Germany
University Hospital Heidelberg, Im Neuenheimer Feld 430 (Site 276608)
Heidelberg, 69120, Germany
University Teaching Centre of the Medical University of Warsaw, 63A, ul. Zwirki i Wigur (Site 616804)
Warsaw, Poland, 02-091, Poland
University Teaching Centre, Department of Pediatrics, Diabetology and Endocrinology (Site 616803)
Gdansk, 80-952, Poland
Institute of Diabetology ul. Raclawicka 129/2U, 02-117 (Site 616802)
Warsaw, 02-117, Poland
Children's Memorial Health Institute Al. Dzieci Polskich 20 (Site 616801)
Warsaw, 04-730, Poland
Sheffield Children's Hospital Western Bank, S10 2TH (Site 826903)
Sheffield, Yorkshire, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2020
First Posted
October 22, 2020
Study Start
October 26, 2020
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
December 9, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org