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: 08 Mar 2017

At a glance

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

    • 02 Mar 2017 Planned End Date changed from 1 Mar 2018 to 1 May 2018.
    • 02 Mar 2017 Planned primary completion date changed from 1 Dec 2017 to 1 Mar 2018.
    • 09 Aug 2016 According to a ProMetic Life Sciences media release, the company has completed the enrollment of the adult patient population (50 adult patients) in cohort 1 and anticipates the completion of enrollment of 25 children in cohort 2.
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