CEPROTIN Registry

• Research type

  Research Study

• Full title

  CEPROTIN Treatment Registry

• IRAS ID

  85488

• Contact name

  Raina Liesner

• Sponsor organisation

  Baxter Healtcare Corporation

• Clinicaltrials.gov Identifier

  NCT01127529

• Research summary

  CEPROTIN is a licensed, highly purified Protein C concentrate developed by Baxter and used in the treatment of protein C deficiency, which if severe results in a hyper-coagulable state and may present with life threatening problems including intravascular coagulation and thromboembolism.The Registry seeks to provide regulatory agencies, clinicians, and scientists with data on the use of and the outcomes associated with CEPROTIN therapy. The Registry is designed as a prospective, international, multi-centre, open-label, non-interventional, observational post authorization study to collect and assess data on the treatment, safety, and treatment outcomes of subjects who are receiving CEPROTIN treatment.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/1737

• Date of REC Opinion

  9 Dec 2011

• REC opinion

  Further Information Favourable Opinion