ArticleThrombosis and haemostasis2026
Pharmacokinetics, Hemostatic Efficacy, and Safety of a New Human Fibrinogen Concentrate in Adult and Pediatric Patients with Congenital Fibrinogen Deficiency.
Article in Thrombosis and haemostasis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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1 citing paper in PubMed.
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Authors and funding
11 authors.
Funding
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Abstract
Congenital fibrinogen deficiencies are rare coagulopathies which are treated by fibrinogen concentrates. This trial investigated the pharmacokinetic/pharmacodynamic (PK/PD) parameters, and surrogate efficacy and safety of a new human fibrinogen concentrate (HFC), BT524, in patients with congenital afibrinogenemia or severe hypofibrinogenemia.This prospective, multi-national, open-label, single-arm PK/PD trial evaluated PK/PD parameters of HFC (part 1; phase I) and HFC as on-demand treatment or prophylaxis for bleeding events (part 2; phase III). In part 1, patients received a single-dose of HFC (70 mg/kg body weight [BW]). PK/PD parameters were calculated using a PK/PD model and non-compartmental analysis. Fibrinogen antigen (FiAg) levels were determined over 14 days by immunonephelometry and fibrinogen activity (FiAc) by Clauss assay. The efficacy variable was mean change in maximum clot firmness (MCF) analyzed by thromboelastometry. Safety parameters were evaluated for 49 days.A total of 27 patients (
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