An open-label study to assess the safety, tolerability and multiple-dose phamacokinetics of AA4500 0.58 mg in subjects with Dupuytren's contractures

Trial Profile

An open-label study to assess the safety, tolerability and multiple-dose phamacokinetics of AA4500 0.58 mg in subjects with Dupuytren's contractures

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jun 2016

At a glance

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

    • 06 Jun 2014 New trial record
    • 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.
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