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