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An Open-label Study to Assess the Safety and Efficacy of Concurrent Administration of Two Injections of AA4500 0.58 mg Into the Same Hand of Subjects With Multiple Dupuytren's Contractures

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Trial Profile

An Open-label Study to Assess the Safety and Efficacy of Concurrent Administration of Two Injections of AA4500 0.58 mg Into the Same Hand of Subjects With Multiple Dupuytren's Contractures

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jul 2015

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At a glance

  • Drugs Collagenase clostridium histolyticum (Primary)
  • Indications Dupuytren's contracture
  • Focus Registrational; Therapeutic Use
  • Sponsors Auxilium Pharmaceuticals
  • Most Recent Events

    • 08 May 2014 According to a Biospecifics Technologies Corporation media release, the supplement biologics license application (sBLA) for potential label expansion of Xiaflex is under FDA review with a PDUFA date of October 20, 2014.
    • 18 Oct 2013 New trial record
    • 07 Oct 2013 Analysis on the use of local anaesthesia reported in a BioSpecifics Technologies Corporation media release and presented at the 68th Annual Meeting of the American Society for Surgery of the Hand (ASSH).

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