Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2007-07-31
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Human Fibrinogen Concentrate
Human Fibrinogen Concentrate
Single intravenous infusion of 70 mg/kg body weight
Interventions
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Human Fibrinogen Concentrate
Single intravenous infusion of 70 mg/kg body weight
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented congenital fibrinogen deficiency: fibrinogen deficiency manifested as afibrinogenemia with plasma fibrinogen activity and antigen at screening undetectable (i.e. \< 20 mg/dL)
* Informed consent signed by subject or legal guardian
Exclusion Criteria
* Presence or history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis
* Acute bleeding
* History of esophageal 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
* Polytrauma within 1 year prior to enrollment
6 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Program Director, Clinical R&D
Role: STUDY_DIRECTOR
CSL Behring
Locations
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Aurora, Colorado, United States
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St. Petersburg, Florida, United States
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Chicago, Illinois, United States
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Scarborough, Maine, United States
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New York, New York, United States
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Pittsburgh, Pennsylvania, United States
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Cagliari, , Italy
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Florence, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Palermo, , Italy
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Rome, , Italy
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Sassari, , Italy
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Vicenza, , Italy
Countries
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References
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Manco-Johnson MJ, Dimichele D, Castaman G, Fremann S, Knaub S, Kalina U, Peyvandi F, Piseddu G, Mannucci P; FIBRINOGEN CONCENTRATE STUDY GROUP. Pharmacokinetics and safety of fibrinogen concentrate. J Thromb Haemost. 2009 Dec;7(12):2064-9. doi: 10.1111/j.1538-7836.2009.03633.x. Epub 2009 Oct 5.
Other Identifiers
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BI3023_2001
Identifier Type: -
Identifier Source: org_study_id
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