Efficacy and safety of Fibrinogen Concentrate (Human) for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiencyFibrinogen Concentrate (Human) (FCH) - efficacy and safety

• Conditions: Congenital fibrinogen deficiency (afibrinogenemia, severe hypofibrinogenemia); MedDRA version: 12.0Level: LLTClassification code 10016075Term: Factor I deficiency

• Registration Number: EUCTR2007-004088-22-DE
• Lead Sponsor: CSL Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-27
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

·Male or female, any age.
·Documented congenital fibrinogen deficiency, expected to require treatment for bleeding:
-Fibrinogen deficiency manifested as afibrinogenemia or severe hypofibrinogenemia (plasma fibrinogen level <50 mg/dL).
-Plasma fibrinogen activity <50 mg/dL and fibrinogen antigen <1.2 times the plasma fibrinogen activity at screening or previously confirmed in Study BI3023_2001. If plasma fibrinogen activity at screening is undetectable, the fibrinogen antigen at screening must be <20 mg/dL.
For those subjects who present to the clinic with an acute bleed without having had a screening visit and who are known to have either afibrinogenemia or severe hypofibrinogenemia (confirmation from medical record or verbal communication to be recorded in source documents), the plasma fibrinogen activity and antigen is to be determined at the CSL Behring laboratory with blood drawn on the day of enrolment (Day 1) and in a non-bleeding state on Day 45, as would have been done at screening.
· Presenting with an episode of acute bleeding (either spontaneous or after trauma) not requiring surgery.
· Provide a signed informed consent (from the subject or their legally authorized representative). A screening informed consent form is to be signed by all subjects who participate in the screening visit and a study informed consent is to be signed by all subjects on Day 1 prior to any study activities.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·Life expectancy <6 months.
·Bleeding disorder other than congenital fibrinogen deficiency, but including dysfibrinogenemia.
·Treatment with:
-Any IMP in the 30 days prior to enrollment (Day 1).
-Any fibrinogen concentrate or other fibrinogen containing blood product in the 2 weeks prior to screening and the 2 weeks prior to enrollment (Day 1).
-Any coagulation active drug (i.e. non-steroidal-antirheumatics, warfarin, cumarin derivates, platelet aggregation inhibitors) in the 2 weeks prior to screening, the 2 weeks prior to enrollment (Day 1), or as a planned or expected medication during the time period from Day 1 until 24 hours after the last FCH infusion.
· Presence or history of:
- nHypersensitivity to FCH.
- Deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment.
- Arterial thrombosis within 1 year prior to enrollment.
- Hypersensitivity to human plasma proteins.
· History or presence of esophageal varicose bleeding.
· End stage liver disease (i.e. Child Pugh score B or C).
· Planned or expected surgery (i.e. for bleedings from aneurysm or splenic rupture).
· Pregnancy, or an intention to become pregnant during the study.
· Currently breast-feeding, or with the intention of breast-feeding during the study.
· Human immunodeficiency virus (HIV) positive.
· Polytrauma, present or within 6 months prior to enrollment.
· Suspicion of an anti fibrinogen inhibitor as indicated by previous IVR (there is no test on inhibitors), if available (<0.5 (mg/dL)/(mg/kg)).
· Previous inclusion and treatment in the prospective part of the study.
· Participation in any clinical study in the 30 days prior to enrollment.

Study & Design

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