NN7999-3895 Trial Evaluating Safety & Efficacy of N9-GP in Haem B PUPs

• Research type

  Research Study

• Full title

  Safety and Efficacy of nonacog beta pegol (N9-GP) in Previously Untreated Patients with Haemophilia B An open-label single-arm multicentre non-controlled phase 3a trial investigating safety and efficacy of nonacog beta pegol (N9-GP) in prophylaxis and treatment of bleeding episodes in previously untreated patients with haemophilia B (FIX activity ≤2%)

• IRAS ID

  145163

• Contact name

  Jayathi Alamelu

• Contact email

  jayanthi.alamelu@gstt.nhs.uk

• Sponsor organisation

  Novo Nordisk Ltd

• Eudract number

  2012-004867-38

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Summary of Research
  An open-label single-arm multicentre non-controlled phase 3a trial investigating safety and efficacy of nonacog beta pegol (N9-GP) in prophylaxis and treatment of bleeding episodes in previously untreated patients with haemophilia B (FIX activity ≤2%)

  Summary of Results
  A lay summary of results can be found at https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.novonordisk-trials.com%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C0cda351ac0fb46d3117508db51453772%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638193129955007834%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=48iw%2BjVA3fjNnPY684r8P5Zhzq9tvp1j%2F37ctsWADks%3D&reserved=0

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  14/WM/0049

• Date of REC Opinion

  26 Mar 2014

• REC opinion

  Further Information Favourable Opinion