3747-Trial evaluating efficacy and safety of NNC-0156-00 in haem B

• Research type

  Research Study

• Full title

  A Multi-centre, Single-Blind Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC-0156-0000-0009 when used for Treatment and Prophylaxis of Bleeding Episodes in Patients with Haemophilia B

• IRAS ID

  69813

• Contact name

  Paul Giangrande

• Sponsor organisation

  Novo Alle

• Eudract number

  2010-023069-24

• 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 in patients with Haemophilia B. The patients and Investigator choose between an on-demand treatment and taking the treatment for prophylaxis. N9-GP is suplied as a freeze-dried powder which is re-constituted with Histidine solvent for I.V. injection. A minimum of 72 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. Subjects will be asked to attend a total of 10 visits in the prophylaxis arm, with the option of PK sampling at Visit 2 & 5, over a 52 week period. Subjects in the on-demand arm will be asked to attend 7 visits over a 28 week period. If a patient is withdrawn or does not continue into the extension trial or the surgery trial then they will be asked to attend a follow-up visit approximately 4 weeks after the end of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/H0505/7

• Date of REC Opinion

  25 Mar 2011

• REC opinion

  Further Information Favourable Opinion