3893-Trial investigating the Pharmacokinetics of NNC 0155-0000-0004

• Research type

  Research Study

• Full title

  Multi-Centre, Open-Label, Randomised Trial Investigating the Pharmacokinetics of a Single Dose of NNC 0155-0000-0004 (N8) in Patients with Haemophilia A

• IRAS ID

  72673

• Contact name

  Charles Hay

• Sponsor organisation

  Novo Nordisk Ltd

• Eudract number

  2010-023921-39

• Research summary

  The NN7008-3893 trial is a phase 1 pharmacokinetics trial which will be used to evaluate the safety of 2 different batches of N8 (trial product) in patients with haemophilia A. It is a European Medicines Agency (EMA) requirement that 3 different batches of N8 are tested. One batch was tested in the phase 1 NN7008-3522 trial (UK did not take part) and the other 2 batches will be used in this trial. The subjects eligible to take part in the study are those that have completed the 3543 N8 pivotal phase 3 trial prior to entry into this study, or subjects who are continuing in the NN7008-3568 N8 phase 3b extension trial. Patients who are continuing in 3568 can be “on hold” from 3568 when participating in this 3893 trial and will continue in 3568 when the present 3893 trial is completed. The duration of trial participation for each subject is expected to be 1 week to 2 months depending on the length of the screening period. Subjects will have a screening visit (visit 1), the PK session after the dose of N8 (visit 2) and an End of Trial (EOT) visit (visit 3). Between visit 1 and 2 the patient will be treated with N8 on the same prophylaxis regimens as they were on for the 3543 or 3568 trials. At visit 2 all patients will receive one dose of N8 as a single intravenous (IV) administration of 50 IU/kg body weight (bw). Blood samples for determination of FVIII activity will be collected within 1 hour prior to, and at 15 min, 30 min, 1, 4, 8, 12, 24, 30 and 48 hours after administration of N8. The EOT visit will be performed on completion of day 3 of visit 2.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0037

• Date of REC Opinion

  27 Apr 2011

• REC opinion

  Further Information Favourable Opinion