Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study

Trial Profile

Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jul 2017

At a glance

  • Drugs Immune globulin (Primary)
  • Indications Chronic inflammatory demyelinating polyradiculoneuropathy
  • Focus Registrational; Therapeutic Use
  • Acronyms PATH
  • Sponsors CSL Behring
  • Most Recent Events

    • 19 Jul 2017 According to a CSL Behring media release, U.S. Food and Drug Administration has accepted Supplemental Biologics License Application for Hizentra for the treatment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment based on data from this study.
    • 27 Jun 2017 Primary endpoint (Percentage (%) of subjects who relapse during the SC treatment period) has been met, as per results published at the 3rd Congress of the European Academy of Neurology.
    • 27 Jun 2017 Results presented at the 3rd Congress of the European Academy of Neurology
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