AUX-CC-810: Long-term Follow-up Study in Men with Peyronie's Disease

• Research type

  Research Study

• Full title

  Long-term safety, curvature deformity characterization, and immunogenicity over time in subjects previously treated with AA4500 for Peyronie's disease in studies AUX-CC-802, AUX-CC-803, AUX-CC-804 and AUX-CC-806.

• IRAS ID

  168090

• Contact name

  Sam Elcomb

• Contact email

  selcomb@auxilium.com

• Sponsor organisation

  Auxilium UK Limited

• Eudract number

  2014-004239-37

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  This study is being conducted to gather long-term data for the safety, immunogenicity and characterisation of penile curvature deformity over time in subjects previously dosed in a clinical study with AA4500 for Peyronie's disease. This is a single centre study involving up to 16 patients previously treated in study AUX-CC-802.
  NB: Studies AUX-CC-803, -804 and -806 also cited in the study title were not performed in the EU.
  

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  14/LO/2186

• Date of REC Opinion

  19 Dec 2014

• REC opinion

  Favourable Opinion