An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency

Completed

Conditions studied: Congenital Fibrinogen Deficiency

In brief

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.

Key facts

Study ID

NCT02427217

Run by

CSL Behring

People needed

22

Starts

2015-05-07

Expected to finish

2017-12-06

Last updated by the study team

2018-01-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• None

Where it is running

• Study Site — Aurora, Colorado, United States
• Study Site — Las Vegas, Nevada, United States
• Study Site — Durham, North Carolina, United States
• Study Site — Calgary, Alberta, Canada
• Study Site — Edmonton, Alberta, Canada
• Study Site — Winnipeg, Manitoba, Canada
• Study Site — Halifax, Nova Scotia, Canada
• Study Site — Hamilton, Ontario, Canada
• Study Site — Toronto, Ontario, Canada
• Study Site — Toronto, Ontario, Canada
• Study Site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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