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Fibrinogen Concentrate Human
Fibrinogen Concentrate Human replaces or supplements deficient fibrinogen to restore normal blood clotting function.
Fibrinogen Concentrate Human replaces or supplements deficient fibrinogen to restore normal blood clotting function. Used for Congenital fibrinogen deficiency (afibrinogenemia or hypofibrinogenemia), Acquired fibrinogen deficiency, Perioperative bleeding management in fibrinogen-deficient patients.
At a glance
| Generic name | Fibrinogen Concentrate Human |
|---|---|
| Also known as | Haemocomplettan, FIBRORAAS, HAEMOCOMPLETTAN P, Chlotafact |
| Sponsor | IRCCS Policlinico S. Donato |
| Drug class | Coagulation factor concentrate |
| Target | Fibrinogen (Factor I) |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Mechanism of action
Fibrinogen (Factor I) is a critical plasma protein essential for the final step of the coagulation cascade, where it is converted to fibrin to form stable blood clots. This concentrate provides exogenous fibrinogen to patients with congenital or acquired fibrinogen deficiency, enabling restoration of hemostatic capacity and reduction of bleeding risk.
Approved indications
- Congenital fibrinogen deficiency (afibrinogenemia or hypofibrinogenemia)
- Acquired fibrinogen deficiency
- Perioperative bleeding management in fibrinogen-deficient patients
Common side effects
- Thromboembolism
- Allergic/hypersensitivity reactions
- Fever
- Headache
- Chills
Key clinical trials
- Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery (PHASE3)
- Comparison of Fibrinogen Concentrate and Cryoprecipitate in Pediatric Cardiac Surgery Patients (PHASE4)
- Administration of Fibrinogen Concentrate for Refractory Bleeding (PHASE2)
- Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency (PHASE3)
- Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency
- Adjusted Fibrinogen Replacement Strategy (PHASE3)
- Fibrin Glue After ESD for High Risk Patients of Bleeding (NA)
- Effectiveness of Different Fibrinogen Preparations in Restoring Clot Firmness (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |