3775-Trial evaluating efficacy & safety of long-term exp NNC-0156-00

• Research type

  Research Study

• Full title

  Safety and Efficacy of NNC-0156-0000-0009 after Long-Term Exposure in Patients with Haemophilia B

• IRAS ID

  70405

• Contact name

  Paul Giangrande

• Eudract number

  2010-023072-17

• 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 after long term exposure in patients with Haemophilia B. After completion of either the pivotal trial (NN7999-3747) or the surgery trial (NN7999-3773) patients may be offered to continue with prophylaxis or on-demand treatment in this extension trial until N9-GP becomes commercially available in the patients respective country or until 01-Jan-2016 (whichever comes first). N9-GP is suplied as a freeze-dried powder which is re-constituted with Histidine solvent for I.V. injection. A minimum of 50 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 patients will initially attend the clinic every 3 months, reducing to every 6 months after Visit 5 until Visit 8. If N9-GP is not commercially available at time of Visit 8, additional visits can be scheduled every 6 months until commercial availability of N9-GP or until 01-Jan-2016 (whichever comes first). If FIX inhibitors develop or are suspected 3 further inhibitor follow up visits will be completed at the end of trial.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  11/H0505/9

• Date of REC Opinion

  8 Apr 2011

• REC opinion

  Further Information Favourable Opinion