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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Nov 2021

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At a glance

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

    • Most Recent Events

    • 29 Apr 2021 According to the CSL Behring media release, based on the data from PATH Extension study, the USA Food and Drug Administration (FDA) has approved a label update for Hizentra (Immune Globulin Subcutaneous [Human] 20% Liquid) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The approval simplifies dosage adjustments between two safe and effective doses proven to prevent CIDP relapse - without the need for intravenous immune globulin treatment in the event of a relapse on the low dose.
    • 20 Jun 2019 According to a CSL Behring media release, new analysis from the PATH study will be presented at the 2019 annual meeting of the Peripheral Nerve Society (PNS, 22nd-26th June,in Genoa, Italy).
    • 26 Mar 2019 According to the CSL Behring media release, based on the data from the PATH and PRIMA trials, Japan's Ministry of Health, Labour and Welfare has approved Privigen [human normal immunoglobulin, 10% liquid, intravenous], ready-to-use therapy for acute and maintenance treatment of chronic inflammatory demyelinating polyradiculoneuropathy.
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