NN7088-3860 Efficacy and Safety of N8-GP during Surgery in Haem A

• Research type

  Research Study

• Full title

  Efficacy and Safety of NNC 0129-0000-1003 during Surgical Procedures in Patients with Haemophilia A (Pathfinder 3)

• IRAS ID

  90934

• Contact name

  Pratima Chowdary

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2011-001144-30

• ISRCTN Number

  n/a

• Research summary

  The trial is a multi-centre, multi-national, open-label, non-randomised, single arm, efficacy and safety trial evaluating N8-GP during surgical procedures in patients with severe (FVIII activity (FVIII:C) < 1%) haemophilia A. This surgery trial NN7088-3860, also referred to as pathfinder?½ 3, consists of a Screening Visit (Visit 1), Day of Surgery (Day 0: Visit 2), Post-operative Period (Days 1-6: Visit 3, Days 7 14: Visit 4) and an End Of Trial (EOT) Visit (Visit 5). Trial Population Patients enrolled in pathfinder?½ 3 will be recruited from the pivotal trial NN7088-3859, also known as pathfinder?½ 2 and upon completion of pathfinder?½ 3, patients will return to pathfinder?½ 2, re-entering the prophylactic or on-demand treatment arm as per their prior participation in the trial. All patients in pathfinder?½ 2 will be offered to enter this trial in case they need major surgery. It is expected that approximately 22 patients with severe (FVIII:C < 1%) haemophilia A already included in pathfinder?½ 2 are to be screened into pathfinder?½ 3 in order to ensure evaluation of at least 15 major surgical procedures in 10-15 patients. If a minimum of 15 major surgeries in minimum 10-15 patients has not yet been performed in this surgery trial by the end of pathfinder?½ 2, the trial might be extended to apply for the patients entering from the extension trial NN7088-3861, also referred to as pathfinder?½ 4. The trial population is characterised by the inclusion and exclusion criteria described in pathfinder?½ 2 and having additional key inclusion and exclusion criteria in this trial.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  12/LO/0026

• Date of REC Opinion

  26 Jan 2012

• REC opinion

  Favourable Opinion