Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)
Public ClinicalTrials.gov record NCT04598893. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT04598893
- Recruitment status
- Active, not recruiting
- Study type
- Observational
- Phase
- Not listed
- Lead sponsor
- Provention Bio, a Sanofi Company
- Industry
- Enrollment
- 188 participants
Conditions and interventions
Conditions
Interventions
- Teplizumab Biological
- Placebo Other
Biological · Other
Eligibility (public fields only)
- Age range
- 9 Years to 19 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 25, 2020
- Primary completion
- Oct 31, 2026
- Completion
- Oct 31, 2026
- Last update posted
- Dec 8, 2025
2020 – 2026
United States locations
- U.S. sites
- 25
- U.S. states
- 17
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rady Children's Hospital 3020 Children's Way (Site 840004) | San Diego | California | 92123 | — |
| UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001) | San Francisco | California | 94158 | — |
| Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002) | Walnut Creek | California | 945981 | — |
| Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005) | Aurora | Colorado | 80045 | — |
| Nemours Children's Health, 807 Children's Way | Jacksonville | Florida | 32207 | — |
| Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048) | St. Petersburg | Florida | 33701 | — |
| Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009) | Atlanta | Georgia | 30318 | — |
| Centricity Research (Site 840006) | Columbus | Georgia | 31904 | — |
| St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052) | Boise | Idaho | 83712 | — |
| Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007) | Idaho Falls | Idaho | 83404 | — |
| Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014) | Indianapolis | Indiana | 46202 | — |
| University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023) | Iowa City | Iowa | 52242 | — |
| Capital Medical Research Associates (Site 840029) | Camp Springs | Maryland | 20746 | — |
| Baystate Medical Center, 759 Chestnut Street | Springfield | Massachusetts | 01199 | — |
| Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026) | Kansas City | Missouri | 64108 | — |
| Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018) | St Louis | Missouri | 63110 | — |
| UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010) | Buffalo | New York | 14203 | — |
| UNC Hospitals, The University of North Carolina at Chapel Hill, Children's Specialty Clinic, 101 Manning Drive (Site 840038) | Chapel Hill | North Carolina | 27514 | — |
| Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034) | Bend | Oregon | 97702 | — |
| Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021) | Philadelphia | Pennsylvania | 19104 | — |
| AM Diabetes & Endocrinology Center, 3025 Kate Bond Rd. (Site 840008) | Bartlett | Tennessee | 38133 | — |
| Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024) | Nashville | Tennessee | 37212 | — |
| UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033) | Dallas | Texas | 75235 | — |
| Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016) | Seattle | Washington | 98101 | — |
| MultiCare Health System, Gateway Medical Building (Site 840003) | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04598893, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 8, 2025 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04598893 live on ClinicalTrials.gov.