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

Active, not recruitingOBSERVATIONAL
Enrollment

188

Participants

Timeline

Start Date

October 26, 2020

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Diabetes Mellitus, Type 1
Interventions
BIOLOGICAL

Teplizumab

Received teplizumab in PROTECT Study

OTHER

Placebo

Received placebo in PROTECT study

Trial Locations (47)

13385

CHU La Timone - La Timone Children's Hospital, Marseille

14203

UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010), Buffalo

19104

Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021), Philadelphia

20746

Capital Medical Research Associates (Site 840029), Camp Springs

21079

Dijon University Hospital Center-Francois Mitterand Hospital, Children's Hospital, Dijon

27514

UNC Hospitals, The University of North Carolina at Chapel Hill, Children's Specialty Clinic, 101 Manning Drive (Site 840038), Chapel Hill

30173

Pediatric Hospital on the Bult Janusz-Korczak-Allee 12 (Site 276604), Hanover

30318

Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009), Atlanta

31904

Centricity Research (Site 840006), Columbus

32207

Nemours Children's Health, 807 Children's Way, Jacksonville

33617

Evangelic Clinic Bethel, Children's Clinic Grenzweg 14/Hs 2 (Site 276602), Bethel

33701

Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048), St. Petersburg

37212

Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024), Nashville

38133

AM Diabetes & Endocrinology Center, 3025 Kate Bond Rd. (Site 840008), Bartlett

45067

Hospital Center Regional D'Orleans Hospital La Source, Pediatric Department, 14 Hospital Ave Post box 86709 (Site 250513), Orléans

46202

Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014), Indianapolis

52242

University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023), Iowa City

63110

Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018), St Louis

64046

Pau Hospital Center, Pau

64108

Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026), Kansas City

69120

University Hospital Heidelberg, Im Neuenheimer Feld 430 (Site 276608), Heidelberg

69677

Woman Mother Child Hospital HCL, Bron

75015

Necker Children's Hospital, 149 Rue de Sevres (Site 250502), Paris

75235

UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033), Dallas

80045

Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005), Aurora

83404

Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007), Idaho Falls

83712

St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052), Boise

86156

Hospital Augsburg, Stenglinstrasse 2 (Site 276606), Augsburg

92123

Rady Children's Hospital 3020 Children's Way (Site 840004), San Diego

94158

UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001), San Francisco

97702

Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034), Bend

98101

Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016), Seattle

98405

MultiCare Health System, Gateway Medical Building (Site 840003), Tacoma

945981

Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002), Walnut Creek

01199

Baystate Medical Center, 759 Chestnut Street, Springfield

B-1090

University Hospital Brussels (Site 056202), Jette

B-5000

UCL Namur University Hospital Place Louise Godin 15 (Site 056205), Namur

T6G 2E1

Alberta Diabetes Institute, 2-004 Li Ka Shing Centre for Health Research Innovation 8602 (Site 124103), Edmundston

V5Y 3W2

BCDiabetes - Medical Research Center, 210 West Broadway Suite 400 (Site 124102), Vancouver

150 06

University Hospital Motol V Uvalu 84, Praha 5 - Motol (Site 203301), Prague

06200

Lenval Hospital, 57 Avenue de la Californie (Site 250508), Nice

01307

University Hospital Carl Gustav Carus Fetscherstrasse 74 (Site 276601), Dresden

80-952

University Teaching Centre, Department of Pediatrics, Diabetology and Endocrinology (Site 616803), Gdansk

02-091

University Teaching Centre of the Medical University of Warsaw, 63A, ul. Zwirki i Wigur (Site 616804), Warsaw

02-117

Institute of Diabetology ul. Raclawicka 129/2U, 02-117 (Site 616802), Warsaw

04-730

Children's Memorial Health Institute Al. Dzieci Polskich 20 (Site 616801), Warsaw

Unknown

Sheffield Children's Hospital Western Bank, S10 2TH (Site 826903), Sheffield

All Listed Sponsors
lead

Provention Bio, a Sanofi Company

INDUSTRY