Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension)
- Conditions
- Diabetes Mellitus, Type 1
- 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
- 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)
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
Nemours Children's Health, 807 Children's Way
🇺🇸Jacksonville, Florida, United States
Johns Hopkins All Children's Hospital, 501 6th Avenue South (Site 840048)
🇺🇸Saint Petersburg, Florida, United States
Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009)
🇺🇸Atlanta, Georgia, United States
Centricity Research (Site 840006)
🇺🇸Columbus, Georgia, United States
St. Luke's Children's Endocrinology, 305 E Jefferson St. (Site 840052)
🇺🇸Boise, Idaho, United States
Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007)
🇺🇸Idaho Falls, Idaho, United States
Scroll for more (37 remaining)Rady Children's Hospital 3020 Children's Way (Site 840004)🇺🇸San Diego, California, United States