NCT02427217

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Congenital Fibrinogen Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	FCH	FCH is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma. FCH is administered as an IV infusion.

Timeline

• Start date: 2015-05-07
• Primary completion: 2017-12-06
• Completion: 2017-12-06
• First posted: 2015-04-27
• Last updated: 2018-01-17

Locations

11 sites across 2 countries: United States, Canada