Forma-01

• Research type

  Research Study

• Full title

  A prospective, controlled, randomised, cross-over study investigating the pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/ RiaSTAP™ in subjects with congenital fibrinogen deficiency

• IRAS ID

  95221

• Contact name

  Savita Rangarajan

• Eudract number

  2011-002403-15

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is a clinical research sponsored by a pharmaceutical company, Octapharma AG, who has developed a new fibrinogen product, called Octafibrin. The main purpose of this study is to test if Octafibrin, a highly purified, lyophilised, human plasma fibrinogen concentrate, is safe and how well it works for prevention of bleeding in subjects suffering from Congenital Fibrinogen Deficiency, also called Congenital Afibrinogenemia, a disorder due to an abnormality in the blood that affects its ability to clot. Plasma fibrinogen concentrate is the first choice for the treatment of congenital fibrinogen deficiency. This study will assess the ??pharmacokinetics? of Octafibrin. This means that blood samples will be taken at different time points to see how active the study drug (Octafibrin) is in the subject??s blood and how long it takes for the study drug to get out of the blood. This will be compared with another drug which is already available on the market in Europe and USA (Haemocomplettan© P/ RiastapTM). This research study consists of a screening visit and 2 pharmacokinetic (PK) periods, each consisting of 45 days; the study participation for each subject will be maximum 146 days (about 5 months). Subjects will be randomised to receive a single infusion of either Octafibrin or Haemocomplettan© P/ RiaSTAPTM in each study period. The study has a cross-over design which means that If the subject has received Octafibrin for the first infusion he/she will receive Haemocomplettan© P/ RiastapTM as the second infusion and if the subject has received Haemocomplettan© P/ RiastapTM for the first infusion he/she will receive Octafibrin for the second one. It will be randomly assigned which product the subject receive first. Randomization is like the flip of a coin.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  12/SC/0177

• Date of REC Opinion

  7 Aug 2012

• REC opinion

  Further Information Favourable Opinion