Post-marketing Observational Study on the Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency

FORMA-07

Open-label, Uncontrolled, Multicenter Observational Study on the Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency

2021-01-28

2027-10-01

2027-10-01

Recruiting

25

Inclusion Criteria: * Patients of any age with a documented diagnosis of congenital afibrinogenemia or hypofibrinogenemia expected to require on-demand in-hospital treatment for BEs with Fibryga Exclusion Criteria: * Bleeding disorder other than congenital fibrinogen deficiency * Patients with acquired fibrinogen deficiency or dysfibrinogenemia * Suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery, if available, of \<0.5 (mg/dL)/(mg/kg); there is currently no standard test for inhibitors * Participation in an interventional clinical study at the time of or within 4 weeks prior to enrolment

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 25, 'type': 'ESTIMATED'}}

2024-02-20