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

CSL Behring

Status: Completed

Conditions: Congenital Fibrinogen Deficiency

Treatments: Biological: FCH

Study type: Observational

Funder types: Industry

Identifiers

NCT02427217

BI3023_4003

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Volunteers: No Healthy Volunteers

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

None

Trial design

22 participants in 1 patient group

Fibrinogen Concentrate, Human (FCH)

Description:

A cohort of subjects who have retrospectively received FCH for the treatment of bleeding, routine prophylaxis and/or use in surgery, and who may continue to prospectively receive FCH at the discretion of the treating physician.

Treatment:

Biological: FCH