3773-Trial demonstrate safety & efficacy of NNC-0156-00 during surgery

• Research type

  Research Study

• Full title

  An open-label, multi-centre, uncontrolled trial to assess efficacy and safety of NNC-0156-0000-0009 during surgical procedures in patients with haemophilia B

• IRAS ID

  71458

• Contact name

  Paul Giangrande

• Sponsor organisation

  Novo Alle

• Eudract number

  2010-023070-40

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The aim of the study is to evaluate the safety and efficacy of N9-GP during surgery in patients with Haemophilia B. N9-GP is suplied as a freeze-dried powder which is re-constituted with Histidine solvent for I.V. injection. A minimum of 16 patients will be screened from the following countries: Canada, France, Hungary, Germany, Italy, Japan, Macedonia, Malaysia, Netherlands, Russia, South Africa, Turkey, Thailand, UK and US. The trial will consist of a Screening visit (for new patients) or a Pre-Surgery visit (for patients transferred from the pivotal trial (NN7999-3747) or the extension trial (NN7999-3775), Day of Surgery and a post-operative period (lasting up to 13 days). If a patient is withdrawn or does not continue into the extension trial or the surgery trial then they will be asked to attend a follow-up visit approximately 4 weeks after the end of trial.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  11/H0505/8

• Date of REC Opinion

  6 Apr 2011

• REC opinion

  Further Information Favourable Opinion