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HELP Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate DX-2930 For Long-Term Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE)

Trial Profile

HELP Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate DX-2930 For Long-Term Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Mar 2022

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At a glance

  • Drugs Lanadelumab (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Acronyms HELP Study
  • Sponsors Dyax; Shire
  • Most Recent Events

    • 28 Mar 2022 According to a Takeda Pharma media release, the company has received approval from the Ministry of Health, Labour and Welfare (MHLW) for TAKHZYRO TAKHZYRO (lanadelumab) subcutaneous injection 300mg syringes for prophylaxis against acute attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older in Japan, based on data from HELP, HELP Study Open-label Extension (OLE) and NCT04180163.
    • 28 Feb 2022 Results of this post-hoc analysis from two studies HELP (NCT02586805) and HELP OLE (NCT02741596) presented at the 2022 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 28 Feb 2022 Post-hoc analysis of HELP and HELP OLE published in Takeda Media Release.
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