Retreatment of recurrent Dupuytren's contractures with AA4500

• Research type

  Research Study

• Full title

  Retreatment of recurrent contractures in joints effectively treated with AA4500 (Collagenase Clostridium Histolyticum Xiaflex/Xiapex)in an Auxilium-sponsored Phase 3 Study in the United States, Australia and Europe.

• IRAS ID

  101917

• Contact name

  Christopher Bainbridge

• Sponsor organisation

  Auxilium UK Limited

• Eudract number

  2011-005065-21

• Clinicaltrials.gov Identifier

  NCT01498640

• Research summary

  The objectives of this study are to assess the safety and efficacy of up to 3 injections of AA4500 in the retreatment of a recurrent Dupuytren's contracture in the joint (a bent finger caused by palpable collagen cord in the hand) that was successfully treated with AA4500 (collagenase clostridium histolyticum (Xiaflex/Xiapex)) in a previous Auxilium sponsored Phase 3 study. Clinical success of the treatment will be defined as the percent change in degree of flexion and actual change in range of motion from before the first injection to each visit to clinic.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  12/SC/0175

• Date of REC Opinion

  4 May 2012

• REC opinion

  Further Information Favourable Opinion