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

NCT04598893

Active Not RecruitingN/A

Sponsor: Provention Bio, a Sanofi Company

Conditions: Diabetes Mellitus, Type 1

Interventions: Teplizumab, Placebo

Countries: United States, Belgium, Canada, Czechia, France, Germany, Poland, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 9 Years to 19 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

1. 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.
2. 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.

Exclusion Criteria:

1\. Premature discontinuation from the PRV-031-001 (PROTECT) study for any reason.
Locations (47)
  • San Diego, California, United States
  • San Francisco, California, United States
  • Walnut Creek, California, United States
  • Aurora, Colorado, United States
  • Jacksonville, Florida, United States
  • St. Petersburg, Florida, United States
  • Atlanta, Georgia, United States
  • Columbus, Georgia, United States
  • Boise, Idaho, United States
  • Idaho Falls, Idaho, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Camp Springs, Maryland, United States
  • Springfield, Massachusetts, United States
  • Kansas City, Missouri, United States
  • St Louis, Missouri, United States
  • Buffalo, New York, United States
  • Chapel Hill, North Carolina, United States
  • Bend, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Bartlett, Tennessee, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Seattle, Washington, United States
  • Tacoma, Washington, United States
  • Jette, Brussels Capital, Belgium
  • Namur, Namur, Belgium
  • Edmundston, Alberta, Canada
  • Vancouver, British Columbia, Canada
  • Prague, Czechia
  • + 17 more on CT.gov