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
Price :
$35
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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
- 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