Xiapex in Dupuytren’s contracture

• Research type

  Research Study

• Full title

  PROSPECTIVE OPEN-LABEL INVESTIGATION OF THE NON-SURGICAL TREATMENT WITH COLLAGENASE CLOSTRIDIUM HISTOLYTICUM XIAPEX® (X)

• IRAS ID

  56954

• Contact name

  David Warwick

• Sponsor organisation

  Pfizer Inc., 235 East 42nd Street, New York, NY 10017

• Eudract number

  2010-019888-10

• ISRCTN Number

  n/a

• Research summary

  iapex is an investigational, injectible drug that is being tested in patients with Dupuytren's disease. Xiapex has been approved by the Regulatory Authorities in the USA, but not in Europe. In Dupuytren's, the tough connective tissue within the hand gradually becomes abnormally thick. This can cause one or more fingers to curl, called a "contracture", especially the small and ring fingers. This can result in pain and impaired function of the fingers. Xiapex consists of 2 enzymes (collagenases) isolated from the bacterium Clostridium histolyticum. These enzymes may help to dissolve the thickened connective tissue seen in Dupuytren's contracture. Xiapex is given as a localised injection in to the affected area of the hand. This study aims to find out how safe and effective Xiapex is in treating patients with Dupuytren's contracture. If subjects meet the eligibility criteria decided by their study doctor and they agree to participate, they will decide which fingers, joints and cords they want treated. They will then receive a single injection of Xiapex in to the selected area. If required, the injection can be repeated each month up to a maximum 3 injections in to any one cord. Subjects can receive up to 5 injections in total. After all injections are completed, subjects will be asked to come back to the study centre after 6 months for their health to be checked. All subjects participating in the trial will receive treatment with Xiapex. The study lasts for up to 11 months, during which time subjects could be asked to visit their study centre up to 23 times, depending on the number of treatments. Two blood samples will be taken, at the start and end of the study. Subjects will also be asked to complete a daily diary and health/activity questionnaires. A pharmaceutical company is funding this study.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  10/H0504/66

• Date of REC Opinion

  10 Nov 2010

• REC opinion

  Further Information Favourable Opinion