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An Open-label, Multicenter, Post-Marketing Requirement Study to Investigate the Safety and Tolerability of Octaplas in the Management of Pediatric Patients Who Require Therapeutic Plasma Exchange

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Trial Profile

An Open-label, Multicenter, Post-Marketing Requirement Study to Investigate the Safety and Tolerability of Octaplas in the Management of Pediatric Patients Who Require Therapeutic Plasma Exchange

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Plasma (Primary)
  • Indications Blood coagulation disorders
  • Focus Adverse reactions
  • Sponsors Octapharma

    • Most Recent Events

    • 29 Mar 2021 According to a Food and Drug Administration media release, the U.S. Food and Drug Administration (FDA) has approved a supplemental Biological License Application which resulted in new product labeling for Octaplas, Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion. The Octaplas labeling now provides the results of two post-marketing studies (LAS-212, LAS-213).
    • 29 Mar 2021 Results presented in a Food and Drug Administration media release.
    • 20 Feb 2020 New trial record

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