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Evaluation of Purified Poloxamer 188 in Children in Crisis (EPIC): A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of ANX-188 (Purified Poloxamer 188) Injection in Children With Sickle Cell Disease Experiencing Vaso Occlusive Crisis

Trial Profile

Evaluation of Purified Poloxamer 188 in Children in Crisis (EPIC): A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial of ANX-188 (Purified Poloxamer 188) Injection in Children With Sickle Cell Disease Experiencing Vaso Occlusive Crisis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Apr 2021

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At a glance

  • Drugs Poloxamer 188 (Primary)
  • Indications Sickle cell anaemia; Vaso-occlusive crisis
  • Focus Registrational; Therapeutic Use
  • Acronyms EPIC
  • Sponsors Mast Therapeutics
  • Most Recent Events

    • 20 Apr 2021 Initial study design included participants aged 8 to 18 years with hemoglobin SS or S-B thalassemia phenotype, but was later amended to allow inclusion of individuals aged 4 to 65 years as well as other SCD phenotypes (hemoglobin SC and S-B+ thalassemia) and also amend to include parenteral preparations of allowed oral opioids.
    • 20 Apr 2021 Primary endpoint (Time (hours) from randomization until the last administration of parenteral opioid analgesic for painful vaso-occlusive episodes prior to hospital discharge.) has not been met, as per results published in the JAMA: the Journal of the American Medical Association
    • 20 Apr 2021 Results published in the JAMA: the Journal of the American Medical Association
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