Status:
WITHDRAWN
Fibrinogen Concentrate (Human) - Efficacy and Safety Study
Lead Sponsor:
CSL Behring
Conditions:
Afibrinogenemia
Hypofibrinogenemia
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
This is a multinational, multicenter, prospective, open-label historically controlled Phase IIIb non-inferiority clinical trial on the efficacy and safety of Fibrinogen Concentrate (Human). It is est...
Eligibility Criteria
Inclusion
- Documented congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia), expected to require treatment for bleeding
- Presenting with an episode of acute bleeding (either spontaneous or after trauma) not requiring surgery
- Provide informed consent
Exclusion
- Life expectancy \< 6 months
- Bleeding disorder other than congenital fibrinogen deficiency, but including dysfibrinogenemia
- Treatment with any investigational medicinal product (IMP) in the 30 days prior to enrollment
- Treatment with any fibrinogen concentrate or other fibrinogen containing blood product in the 2 weeks prior to enrollment
- Treatment with any coagulation active drug (i.e., non-steroidal-antirheumatics, warfarin, cumarin derivates, platelet aggregation inhibitors) in 1 week prior to enrollment 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 hypersensitivity to FCH
- Presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment
- Presence or history of arterial thrombosis within 1 year prior to enrollment
- Presence or history of hypersensitivity to human plasma proteins
- Presence or history 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 in-vivo recovery (IVR), 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00916656
Start Date
October 1 2009
End Date
March 1 2014
Last Update
February 6 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.