Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Biological: TeplizumabOther: Placebo
- Registration Number
- NCT04598893
- Lead Sponsor
- Provention Bio, a Sanofi Company
- Brief 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.
- Detailed Description
This study is the long-term extension of the PRV-031-001 (PROTECT) study. PROTECT is a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center study to evaluate the efficacy and safety of teplizumab, a humanized, anti-CD3 monoclonal antibody, in children and adolescents ages 8 through 17 recently diagnosed with type 1 diabetes (within 6 weeks of diagnosis) in which approximately 300 participants were randomized at a ratio of 2:1 to the teplizumab or placebo and received two courses of treatment administered 6 or 12 months apart with final follow-up at approximately 18 months (78 weeks) after the first dose.
Participants who complete the PROTECT study are invited to enroll in this observational, extension study to collect long-term safety and other clinical data. The decision to participate can be made within 12 months of completing the PROTECT study.
No study drug will be administered during this extension study. Participants will continue to receive standard care for type 1 diabetes from their primary physicians.
Participants will return to the study sites for assessments once every 6 months through Month 42. Therefore, the combined duration of the PROTECT and PROTECT Extension studies will be 60 months.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 188
- 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.
- Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Teplizumab Teplizumab Participants who received teplizumab in the PROTECT study Placebo Placebo Participants who received placebo in the PROTECT study
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies During 42 months of follow-up Safety outcome
- Secondary Outcome Measures
Name Time Method Area under the time-versus concentration curve (AUC) of C-peptide after a 4-hour (4h) mixed-meal tolerance test (MMTT) During the 42 months of follow-up Clinical parameters of diabetes management 1
Insulin use (daily average insulin dose in U/kg/day) During the 42 months of follow-up Clinical parameters of diabetes management 2
HbA1c During the 42 months of follow-up Clinical parameters of diabetes management 3
Trial Locations
- Locations (47)
Indiana University Hospital, Indiana Clinical Research Center, 550 North University Boulevard (Site 840014)
🇺🇸Indianapolis, Indiana, United States
Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007)
🇺🇸Idaho Falls, Idaho, United States
Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021)
🇺🇸Philadelphia, Pennsylvania, United States
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
Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009)
🇺🇸Atlanta, Georgia, United States
University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023)
🇺🇸Iowa City, Iowa, United States
Baystate Medical Center, 759 Chestnut Street
🇺🇸Springfield, Massachusetts, United States
Capital Medical Research Associates (Site 840029)
🇺🇸Camp Springs, Maryland, United States
Centricity Research (Site 840006)
🇺🇸Columbus, Georgia, United States
Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048)
🇺🇸Saint Petersburg, Florida, United States
St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052)
🇺🇸Boise, Idaho, 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
University Hospital Brussels (Site 056202)
🇧🇪Jette, Brussels, Belgium
Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034)
🇺🇸Bend, Oregon, United States
AM Diabetes & Endocrinology Center, 3025 Kate Bond Rd. (Site 840008)
🇺🇸Bartlett, Tennessee, United States
Dijon University Hospital Center-Francois Mitterand Hospital, Children's Hospital
🇫🇷Dijon Cedex, France
CHU La Timone - La Timone Children's Hospital
🇫🇷Marseille, France
Evangelic Clinic Bethel, Children's Clinic Grenzweg 14/Hs 2 (Site 276602)
🇩🇪Bethel, Bielefeld, Germany
Necker Children's Hospital, 149 Rue de Sevres (Site 250502)
🇫🇷Paris, France
UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033)
🇺🇸Dallas, Texas, United States
UCL Namur University Hospital Place Louise Godin 15 (Site 056205)
🇧🇪Namur, Belgium
Alberta Diabetes Institute, 2-004 Li Ka Shing Centre for Health Research Innovation 8602 (Site 124103)
🇨🇦Edmundston, Alberta, Canada
Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016)
🇺🇸Seattle, Washington, United States
Woman Mother Child Hospital HCL
🇫🇷Bron, France
Lenval Hospital, 57 Avenue de la Californie (Site 250508)
🇫🇷Nice, France
University Hospital Motol V Uvalu 84, Praha 5 - Motol (Site 203301)
🇨🇿Prague, Czechia
University Teaching Centre, Department of Pediatrics, Diabetology and Endocrinology (Site 616803)
🇵🇱Gdansk, Poland
Hospital Augsburg, Stenglinstrasse 2 (Site 276606)
🇩🇪Augsburg, Germany
Pediatric Hospital on the Bult Janusz-Korczak-Allee 12 (Site 276604)
🇩🇪Hannover, Germany
University Teaching Centre of the Medical University of Warsaw, 63A, ul. Zwirki i Wigur (Site 616804)
🇵🇱Warsaw, Poland
Institute of Diabetology ul. Raclawicka 129/2U, 02-117 (Site 616802)
🇵🇱Warsaw, Poland
Children's Memorial Health Institute Al. Dzieci Polskich 20 (Site 616801)
🇵🇱Warsaw, Poland
Sheffield Children's Hospital Western Bank, S10 2TH (Site 826903)
🇬🇧Sheffield, Yorkshire, United Kingdom
Hospital Center Regional D'Orleans Hospital La Source, Pediatric Department, 14 Hospital Ave Post box 86709 (Site 250513)
🇫🇷Orleans, France
Pau Hospital Center
🇫🇷Pau, France
Washington University School of Medicine, Pediatric Clinical Research Unit, Suite 11W19 (Site 840018)
🇺🇸Saint Louis, Missouri, United States
Nemours Children's Health, 807 Children's Way
🇺🇸Jacksonville, Florida, United States
Children's Mercy Hospitals and Clinics, 2401 Gillham Road (Site 840026)
🇺🇸Kansas City, Missouri, United States
UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010)
🇺🇸Buffalo, New York, United States
MultiCare Health System, Gateway Medical Building (Site 840003)
🇺🇸Tacoma, Washington, United States
University Hospital Carl Gustav Carus Fetscherstrasse 74 (Site 276601)
🇩🇪Dresden, Germany
University Hospital Heidelberg, Im Neuenheimer Feld 430 (Site 276608)
🇩🇪Heidelberg, Germany
Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024)
🇺🇸Nashville, Tennessee, United States
BCDiabetes - Medical Research Center, 210 West Broadway Suite 400 (Site 124102)
🇨🇦Vancouver, British Columbia, Canada