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NCT04598893 · ClinicalTrials.gov registry record
Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)
A clinical trial of Diabetes Mellitus, Type 1, sponsored by Provention Bio, a Sanofi Company.
- Active
- Registry status
- 188
- Enrollment target
- 20
- Study locations
NCT04598893: Active study of Diabetes Mellitus, Type 1, sponsored by Provention Bio, a Sanofi Company.
NCT04598893 is a study of Diabetes Mellitus, Type 1 that is active but no longer recruiting, run by Provention Bio, a Sanofi Company. The registered enrollment target is 188 participants, below the 1,265-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04598893, a study of Diabetes Mellitus, Type 1, is active but no longer recruiting, sponsored by Provention Bio, a Sanofi Company.
- ACTIVE NOT RECRUITING
- Registry status
- 188 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Safety outcome
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Teplizumab
Study Locations (20)
California
- Rady Children's Hospital 3020 Children's Way (Site 840004) - San Diego
- UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001) - San Francisco
- Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002) - Walnut Creek
Florida
- Nemours Children's Health, 807 Children's Way - Jacksonville
- Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048) - St. Petersburg
Georgia
- Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009) - Atlanta
- Centricity Research (Site 840006) - Columbus
Idaho
- St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052) - Boise
- Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007) - Idaho Falls
Missouri
- Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026) - Kansas City
- Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018) - St Louis
Colorado
- Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005) - Aurora
Indiana
- Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014) - Indianapolis
Iowa
- University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023) - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2020-10-26 |
| Est. Completion | 2026-11 |
What the registry record for NCT04598893 still lists
NCT04598893 is an observational study that tracks outcomes without assigning an intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 1,265-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04598893 names 20 study sites across 14 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04598893 about?
NCT04598893 is a clinical study titled "Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)". 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.
What is the current status of trial NCT04598893?
This trial is currently active not recruiting. The enrollment target is 188 participants. The study started on 2020-10-26. Estimated completion is 2026-11.
What conditions does trial NCT04598893 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT04598893?
The interventions under investigation include: Placebo (OTHER), Teplizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04598893?
This trial is sponsored by Provention Bio, a Sanofi Company, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04598893 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04598893's enrollment target sits among peer trials
188 33rd of 118 higher than 86 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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