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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04598893
The ClinicalTrials.gov registry entry for NCT04598893 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,265-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (85% lower). The listed sponsor is Provention Bio, a Sanofi Company, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.