Octafibrin in Congenital Fibrinogen Deficiency - FORMA-02

• Research type

  Research Study

• Full title

  Prospective, open-label, uncontrolled, Phase III study to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during and after surgery in subjects with congenital fibrinogen deficiency.

• IRAS ID

  153951

• Contact name

  Savita Rangarajan

• Contact email

  Savita.Rangarajan@hhft.nhs.uk

• Sponsor organisation

  Octapharma AG

• Eudract number

  2011-002419-27

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  14/SC/0265

• Date of REC Opinion

  29 May 2014

• REC opinion

  Favourable Opinion