GENA-13 (follow-up study to REC reference number 10/H0706/48)

• Research type

  Research Study

• Full title

  Clinical Study in Previously Treated Children with Severe Haemophilia A to Investigate the Long-Term Immunogenicity, Tolerability and Efficacy of Human-cl rhFVIII

• IRAS ID

  84312

• Sponsor organisation

  Octapharma AG

• Eudract number

  2011-001785-17

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Octapharma is developing a recombinant human factor VIII concentrate (human cell line rhFVIII) for the treatment of haemophilia A. Human cell line rhFVIII (Human-cl rhFVIII) has been developed with the specific aim to have the same efficacy properties as human plasma derived or other recombinant FVIII concentrates in the treatment of haemophilia A. Human-cl rhFVIII is a fourth-generation recombinant factor VIII (rFVIII) concentrate developed by Octapharma for control and prevention of bleeding episodes and for surgical prophylaxis in patients with haemophilia A.Dosing recommendations in GENA-13 are the same as in the preceding GENA-03 study.Number of study center(s): About 12 - 18 centres in UK, Austria, Czech Republic, Poland, Russia, Turkey and France.Study duration: 3rd Quarter 2011 until 1st Quarter 2014 (as soon as Human-cl rhFVIII is launched in the respective country).Number of subjects: A maximum of 60 subjects who completed study GENA-03 will be enrolled.Description and duration of treatment: Subjects will enter the study on the day of completion of the preceding study GENA-03, and are thereafter given the possibility to use Human-cl rhFVIII until its launch in the respective country of conductance. Thus, individual study participation periods are possible, varying from country to country.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  11/LO/1159

• Date of REC Opinion

  27 Sep 2011

• REC opinion

  Further Information Favourable Opinion