🏛️ Verified NIH Record • Updated 2025-12-02
Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension) (NCT04598893)
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
🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Provention Bio, a Sanofi Company
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Rady Children's Hospital 3020 Children's Way (Site 840004) — San Diego, California
Age range: 9 Years to 19 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (47 Sites)
Showing the first 25 of 47 sites.
- Rady Children's Hospital 3020 Children's Way (Site 840004) — San Diego, California
- UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001) — San Francisco, California
- Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002) — Walnut Creek, California
- Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005) — Aurora, Colorado
- Nemours Children's Health, 807 Children's Way — Jacksonville, Florida
- Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048) — St. Petersburg, Florida
- Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009) — Atlanta, Georgia
- Centricity Research (Site 840006) — Columbus, Georgia
- St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052) — Boise, Idaho
- Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007) — Idaho Falls, Idaho
- Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014) — Indianapolis, Indiana
- University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023) — Iowa City, Iowa
- Capital Medical Research Associates (Site 840029) — Camp Springs, Maryland
- Baystate Medical Center, 759 Chestnut Street — Springfield, Massachusetts
- Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026) — Kansas City, Missouri
- Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018) — St Louis, Missouri
- UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010) — Buffalo, New York
- UNC Hospitals, The University of North Carolina at Chapel Hill, Children's Specialty Clinic, 101 Manning Drive (Site 840038) — Chapel Hill, North Carolina
- Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034) — Bend, Oregon
- Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021) — Philadelphia, Pennsylvania
- AM Diabetes & Endocrinology Center, 3025 Kate Bond Rd. (Site 840008) — Bartlett, Tennessee
- Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024) — Nashville, Tennessee
- UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033) — Dallas, Texas
- Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016) — Seattle, Washington
- MultiCare Health System, Gateway Medical Building (Site 840003) — Tacoma, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Diabetes Mellitus, Type 1 clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.