NCT04598893Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Observational
- Enrollment
- 188 (actual)
- First submitted
- 16 Oct 2020
- Start date
- 26 Oct 2020
- Primary completion date
- Nov 2026
- Lead sponsor
- Provention Bio, a Sanofi Company
- Diseases
- Type 1 diabetes
- NCT number
- NCT04598893
- EU CT number
- 2024-516543-26-00
- EudraCT number
- 2020-002798-92
What you commit to
- Study type: Observational · Phase 3
- Participants enrolled: 188
- From 26 Oct 2020 to the primary completion date, Nov 2026
- 44 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 1\. Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.
Who the study is looking for
- 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.
Age in the registry: 9 years to 19 years · Sex: All · Does not accept healthy volunteers
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Namur | Belgium | Completed |
| Alberta Diabetes Institute, 2-004 Li Ka Shing Centre for Health Research Innovation 8602 (Site 124103) Coordinator of this site? Confirm its status | Edmundston | Canada | Unknown status |
| BCDiabetes - Medical Research Center, 210 West Broadway Suite 400 (Site 124102) Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Universitaetsklinikum Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Completed |
| Evangelisches Klinikum Bethel gGmbH Coordinator of this site? Confirm its status | Bielefeld | Germany | Completed |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Hospital Femme Mere Enfant Coordinator of this site? Confirm its status | Bron | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Active, not recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Centre Hospitalier Universitaire D Orleans Coordinator of this site? Confirm its status | Orleans Cedex 2 | France | Active, not recruiting |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier de Pau Coordinator of this site? Confirm its status | Pau | France | Active, not recruiting |
| Sheffield Children's Hospital Western Bank, S10 2TH (Site 826903) Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Instytut Diabetologii.sp.z.o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009) Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005) Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| AM Diabetes & Endocrinology Center, 3025 Kate Bond Rd. (Site 840008) Coordinator of this site? Confirm its status | Bartlett | United States | Unknown status |
| Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034) Coordinator of this site? Confirm its status | Bend | United States | Unknown status |
| St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052) Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010) Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Capital Medical Research Associates (Site 840029) Coordinator of this site? Confirm its status | Camp Springs | United States | Unknown status |
| UNC Hospitals, The University of North Carolina at Chapel Hill, Children's Specialty Clinic, 101 Manning Drive (Site 840038) Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Centricity Research (Site 840006) Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033) Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007) Coordinator of this site? Confirm its status | Idaho Falls | United States | Unknown status |
| Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014) Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023) Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Nemours Children's Health, 807 Children's Way Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026) Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024) Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021) Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Rady Children's Hospital 3020 Children's Way (Site 840004) Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001) Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016) Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Baystate Medical Center, 759 Chestnut Street Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018) Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048) Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| MultiCare Health System, Gateway Medical Building (Site 840003) Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002) Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.