A Phase 3, Multinational, Multicenter, Open-Label Study of the Safety, Tolerability, Efficacy, and PK of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10% in Adults and Children With PID

Trial Profile

A Phase 3, Multinational, Multicenter, Open-Label Study of the Safety, Tolerability, Efficacy, and PK of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10% in Adults and Children With PID

Recruiting
Phase of Trial: Phase III

Latest Information Update: 22 Nov 2017

At a glance

  • Drugs Immune globulin (Primary)
  • Indications Immunodeficiency disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors ProMetic Life Sciences
  • Most Recent Events

    • 22 Nov 2017 According to a Prometic media release, interim results from this trial are sufficient to complete the clinical portion of the New Drug Submission (NDS) with Health Canada.
    • 22 Nov 2017 Interim six-month data presented in a Prometic media release.
    • 02 Mar 2017 Planned End Date changed from 1 Mar 2018 to 1 May 2018.
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