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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jul 2015

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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