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An Open-label, Multicenter, Post-Marketing Requirement (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors

Trial Profile

An Open-label, Multicenter, Post-Marketing Requirement (PMR) Study to Investigate the Safety, Tolerability and Efficacy of Octaplas in the Management of Pediatric Patients Who Require Replacement of Multiple Coagulation Factors

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 22 May 2019

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At a glance

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

    • 22 May 2019 Results presented in an Octapharma media release.
    • 22 May 2019 According to an Octapharma media release, this study results demonstrating the safety of Octaplas in the management of critically ill pediatric patients were presented at the Society of Cardiovascular Anesthesiologists Annual Meeting.
    • 22 May 2019 According to an Octapharma media release, the U.S. Food and Drug Administration (FDA) has approved a revised product label for Octapharma USAs Octaplas, pooled plasma (Human), solvent/detergent treated solution for intravenous infusion.The new labeling provides the results of this post-marketing study that demonstrates the products (Octaplas) safety, efficacy and tolerability in treating critically ill pediatric patients who require replacement of multiple coagulation factors.
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