NN7088-3859 Trial Evaluating Safety and Efficacy of N8-GP in Haem A

• Research type

  Research Study

• Full title

  A Multi-national Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC 0129-0000-1003 when Administered for Treatment and Prophylaxis of Bleeding in Patients with Haemophilia A (Pathfinder 2)

• IRAS ID

  90373

• Contact name

  Pratima Chowdary

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2011-001142-15

• ISRCTN Number

  n/a

• Research summary

  The aim of the study is to evaluate the safety and efficacy of N8-GP in patients with Haemophilia A. The patients and Investigator choose between an on-demand treatment and taking the treatment for prophylaxis. N8-GP is suplied as a freeze-dried powder which is re-constituted with sodium chlordie solution for I.V. injection. A minimum of 150 patients will be screened from the following countries: Australia, Brazil, Croatia, Denmark, France, Germany, Hungary, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Russia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and United States Subjects will be asked to attend a total of 13 visits in the prophylaxis and on-demand arm over a 79 week period. Subjects in the prophylaxis arm will have the option of taking part in pharmacokinetic sampling at visits 2 and 7. If a patient is withdrawn or does not continue into the extension trial or the surgery trial then they will be asked to attend a follow-up visit approximately 1 month after the end of trial. If a patient develops inhibitors to the trial product then they will be asked to attend follow up visits to monitor the levels of inhibitors. All patients will complete at least 7 visits depending on when they are enrolled in the trial as the trial will be completed when the last patient has had 50 Exposure Days (EDs). The last patient will have End Of Trial visit at visit 7 after having received at least 50 EDs whereas the first patient enrolled in the trial will have the EOT visit at Visit 13.Therefore, the EOT visit can be all visits from visit 7 to visit 13. More visits may be added depending on when the last patient has had at least 50 EDs.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  12/LO/0025

• Date of REC Opinion

  26 Jan 2012

• REC opinion

  Favourable Opinion