Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)

Running, not enrolling · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT04598893

Run by

Provention Bio, a Sanofi Company

People needed

188

Starts

2020-10-26

Expected to finish

2026-11-01

Last updated by the study team

2025-12-09

Who can join

Age: 9 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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