- * Male or female subjects of any age with a diagnosis of congenital fibrinogen deficiency.
- * Have received FCH (Haemocomplettan® P or RiaSTAP®) for treatment of bleeding, surgery or prophylaxis.
Congenital Fibrinogen Deficiency
An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency
NCT02427217 | PHASE 3 | OBSERVATIONAL
This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency. Data will be collected on the safety and efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis and perioperative bleeding in these subjects. All subjects have received FCH and may continue to receive FCH at the discretion of the treating physician / Primary Investigator according to the standard of care at the participating study site.
Trial Information
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Study Site
Aurora,Colorado,United States,80045
Study Site
Las Vegas,Nevada,United States,89109
Study Site
Durham,North Carolina,United States,27705
Study Site
Calgary,Alberta,Canada,T2N2T9
Study Site
Edmonton,Alberta,Canada,T6G2H7
Study Site
Winnipeg,Manitoba,Canada,R3E0V9
Study Site
Halifax,Nova Scotia,Canada,B3H2Y9
Study Site
Hamilton,Ontario,Canada,L8S3Z5
Study Site
Toronto,Ontario,Canada,M5B1W8
Study Site
Toronto,Ontario,Canada,M5G1X8
Study Site
Montreal,Quebec,Canada,H3T1C5
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov