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

Congenital Fibrinogen Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427217
• Other study ID #: BI3023_4003
• Status: Completed
• Phase: N/A
• First received: April 22, 2015
• Last updated: January 12, 2018
• Start date: May 7, 2015
• Est. completion date: December 6, 2017

Study information

• Verified date: January 2018
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 6, 2017
• Est. primary completion date: December 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Afibrinogenemia
• Congenital Fibrinogen Deficiency

Intervention

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.

Locations

Country	Name	City	State
Canada	Study Site	Calgary	Alberta
Canada	Study Site	Edmonton	Alberta
Canada	Study Site	Halifax	Nova Scotia
Canada	Study Site	Hamilton	Ontario
Canada	Study Site	Montreal	Quebec
Canada	Study Site	Toronto	Ontario
Canada	Study Site	Toronto	Ontario
Canada	Study Site	Winnipeg	Manitoba
United States	Study Site	Aurora	Colorado
United States	Study Site	Durham	North Carolina
United States	Study Site	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants achieving hemostatic efficacy - retrospective	The investigator's overall assessment of hemostatic efficacy of FCH from a review of the subject's historical records.	From the subject's first use of FCH, up to approximately 20 years.
Secondary	Percentage of participants achieving hemostatic efficacy - prospective	The investigator's overall assessment of hemostatic efficacy of FCH during the prospective follow-up period.	Approximately 12 months
Secondary	Percentage of participants with adverse events		Retrospective data collection is from the subject's first use of FCH (up to approximately 20 years); Prospective data collection is from the time of informed consent up to approximately 12 months.