A Phase 3b Open-label, Historically-controlled Study to Assess the Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures With Palpable Cords

Trial Profile

A Phase 3b Open-label, Historically-controlled Study to Assess the Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures With Palpable Cords

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Feb 2016

At a glance

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

    • 26 Feb 2016 According to a Swedish Orphan Biovitrum media release, Xiapex (collagenase clostridium histolyticum) has been approved in EU for the treatment of two Dupuytren's contracture cords concurrently.
    • 17 Jul 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 08 May 2014 According to a Biospecifics Technologies Corporation media release, the supplement biologics license application (sBLA) of Xiaflex for treating multiple Dupuytren's contracture cord is under FDA review with a PDUFA date of October 20, 2014.
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