Status:
TERMINATED
Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency
Lead Sponsor:
Octapharma
Conditions:
Congenital Fibrinogen Deficiency
Eligibility:
All Genders
Brief Summary
Open-label, Uncontrolled, Multicenter Observational Study on the Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency
Detailed Description
There is a need to increase the body of data on treatment effectiveness and safety in the ultra-rare setting of congenital fibrinogen deficiency. Real-world evidence (RWE) derived from non-interventio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 14 2025
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03793426
Start Date
January 28 2021
End Date
May 14 2025
Last Update
June 24 2025
Active Locations (4)
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1
Fakultní nemocnice Ostrava
Ostrava, Czechia
2
Gerinnungszentrum rhein-ruhr
Duisburg, Germany
3
Medizinische Klinik 2 / Institut für Transfusionsmedizin Universitätsklinikum
Frankfurt, Germany
4
Gerinnungszentrum Hochtaunus
Hamburg, Germany