A Phase 3 clinical study of lumasiran for treatment of Primary-hyperoxaluria type 1 (PH1)

Trial Profile

A Phase 3 clinical study of lumasiran for treatment of Primary-hyperoxaluria type 1 (PH1)

Planning
Phase of Trial: Phase III

Latest Information Update: 03 May 2018

At a glance

  • Drugs Lumasiran (Primary)
  • Indications Primary hyperoxaluria
  • Focus Registrational; Therapeutic Use
  • Sponsors Alnylam Pharmaceuticals
  • Most Recent Events

    • 03 May 2018 According to an Alnylam media release, the Company has reached alignment with the U.S. Food and Drug Administration (FDA) on a primary endpoint for the pivotal study based on reduction of urinary oxalate at six months and on a study size of approximately 25 patients with PH1.
    • 03 May 2018 According to an Alnylam media release, the company plans to initiate the study in mid-2018 and expects to report top-line results in 2019, if positive an NDA will be submitted in early 2020.
    • 15 Mar 2018 New trial record
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