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A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AMG0001 in Subjects With Critical Limb Ischemia

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Trial Profile

A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AMG0001 in Subjects With Critical Limb Ischemia

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2022

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At a glance

  • Drugs Beperminogene perplasmid (Primary)
  • Indications Chronic limb-threatening ischemia; Peripheral ischaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors AnGes

Most Recent Events

  • 07 Sep 2022 According to an AnGes media release, the company has completed administration in the trial and have been organizing and analyzing the data, as a result of which, it found that it failed to meet the primary endpoints. Based on this, the company has decided to discontinue the development for approval of the HGF gene therapy product in Japan for the additional indication of chronic arterial occlusive disease with rest pain.
  • 26 Mar 2017 This trial has been completed in Hungary (end date: 6 Mar 2017).
  • 23 Mar 2017 This trial has been completed in Spain (end date: 6 Mar 2017).

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