An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/19/2018 |
| Start Date: | May 7, 2015 |
| End Date: | December 6, 2017 |
A Multicenter Study on the Retrospective Safety and Efficacy of Fibrinogen Concentrate (Human) (FCH) for Routine Prophylaxis, Treatment of Bleeding or Surgery in Subjects With Congenital Fibrinogen Deficiency With a Prospective Followup Component
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
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4
sites
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