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A Confirmatory Study for Post-Approval Evaluation of Patients who Receive Treatment with HGF Plasmid (Collategene)

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Trial Profile

A Confirmatory Study for Post-Approval Evaluation of Patients who Receive Treatment with HGF Plasmid (Collategene)

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 02 Jul 2024

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At a glance

  • Drugs Beperminogene perplasmid (Primary)
  • Indications Arteriosclerosis obliterans; Chronic limb-threatening ischemia; Peripheral arterial disorders
  • Focus Therapeutic Use

    • Most Recent Events

    • 24 Jun 2024 According to an AnGes media release, post-marketing surveillance conducted under open-label conditions could not reproduce the results of the double-blind domestic Phase III clinical trial, application (conditional and time-limited marketing approval in Japan for Collategene), temporarily withdrawn, and company will build an application data package centered on results of domestic Phase III clinical trial and Phase II clinical trial in the U.S.
    • 04 Sep 2019 According to an AnGes MG media release, Mitsubishi Tanabe Pharma has been commissioned by AnGes to conduct this confirmatory study as the post-approval evaluation.
    • 15 Apr 2019 New trial record

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