A controlled, randomised, study investigating thepharmacokinetic properties (to see how active the study drug is in your blood and how long it takes for the study drug to get out of your blood) ,surrogate efficacy and safety of Octafibrin compared toHaemocomplettan® P/ RiaSTAPTM in subjects with congenital fibrinogen deficiency

• Conditions: congenital fibrinogen deficiency; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2011-002403-15-IT
• Lead Sponsor: OCTAPHARMA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-15
• Last Update Posted: 23 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Subject age =12 years
• Documented congenital fibrinogen deficiency (afibrinogenaemia)
Plasma fibrinogen activity and antigen at screening bellow detection limit (i.e. <20mg/dl)
• Informed consent signed by subject or legal guardian
Are the trial subjects under 18? yes
Number of subjects for this age range: 6
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

• Life expectancy <6 months
• Bleeding disorder other than congenital fibrinogen deficiency
• Dysfibrinogenemia
• Treatment with:
Any fibrinogen concentrate or other fibrinogen-containing blood product in the 2 weeks prior to enrolment
• Presence or history of:
Hypersensitivity to study medication
­ Deep vein thrombosis or pulmonary embolism within 1 year prior to enrolment
­ Arterial thrombosis within 1 year prior to enrolment
­ Hypersensitivity to human plasma proteins
? Acute bleeding
? History of oesophageal varicose bleeding
? End-stage liver disease (i.e. Child-Pugh-score B or C)
? Planned major surgery with a need for blood transfusion during the PK blood-sampling period of this study
? Pregnancy, or an intention to become pregnant during the study
? Currently breast-feeding, or with the intention of breast-feeding during the study
? HIV positive with a viral load >200 particles/µl ~ >400000 copies/ml
? Polytrauma 1 year prior to enrolment
? Suspicion of an anti-fibrinogen inhibitor as indicated by previous in-vivo recovery, if available 0.5 (mg/dl)/(mg/kg), (there is currently no standard test for inhibitors)<br? Blood or plasma donation in the 3 months prior to enrolment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified