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A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Recent-Onset Type 1 Diabetes Mellitus

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A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Recent-Onset Type 1 Diabetes Mellitus

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2024

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At a glance

  • Drugs Teplizumab (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Adverse reactions
  • Acronyms PROTECT Extension
  • Sponsors Provention Bio

    • Most Recent Events

    • 05 Jan 2024 Planned End Date changed from 1 Jun 2026 to 1 Nov 2026.
    • 05 Jan 2024 Planned primary completion date changed from 1 Jun 2026 to 1 Nov 2026.
    • 05 Jan 2024 Status changed from recruiting to active, no longer recruiting.

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