Study of HEMOLEVEN in severe FXI deficiency patients, v. 13.0

• Research type

  Research Study

• Full title

  Pharmacokinetic and Safety Study of Human Coagulation Factor XI (HEMOLEVEN) in Patients with Severe Inherited Factor XI Deficiency

• IRAS ID

  111209

• Contact name

  Charles Hay

• Sponsor organisation

  LFB Biotechnologies

• Eudract number

  2007-002068-86

• Research summary

  The purpose of this clinical study is to evaluate the behaviour of the study drug, HEMOLEVEN (human coagulation factor XI), in the human body over time. This kind of study called a ‘pharmacokinetic study’ will be conducted in hemophilia centres. Patients in a non-bleeding state with a severe inherited FXI deficiency will be recruited. Patients, after having read an information sheet and signed a consent form, will undergo through a screening phase during which the study doctor will evaluate if the patient is eligible to participate to the study. If eligible, the patient will receive a single intravenous injection of 20IU/Kg of HEMOLEVEN and then blood samples will be drawn from the patient at several time points over a period of height days(Pharmacokinetic period). Then, the patient will perform a final study visit in order to follow up the safety of the treatment. The total duration of participation of a patient will not exceed three months.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  12/NW/0626

• Date of REC Opinion

  2 Jan 2013

• REC opinion

  Further Information Favourable Opinion