ArticleResearch and practice in thrombosis and haemostasis2025
Trenonacog alfa safety, efficacy, and pharmacokinetics in previously treated pediatric hemophilia B.
Article in Research and practice in thrombosis and haemostasis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Trenonacog alfa is a recombinant factor IX approved for adolescents and adults with hemophilia B. Objectives: The aim of this study was to assess the pharmacokinetics (PK), efficacy as prophylaxis, control of bleeding episodes, and safety of trenonacog alfa in previously treated participants aged <12 years with severe or moderately severe hemophilia B and no current or history of inhibitors. Methods: The study had 3 phases: (1) PK evaluation after a single infusion of 75 ± 5 IU/kg, (2) treatment phase in which participants received trenonacog alfa prophylaxis 35 to 75 IU/kg for 50 exposure days, and (3) a continuation phase in which prophylaxis could be administered for ≥50 additional exposure days. Results: The PK of trenonacog alfa was comparable between adolescents and adults except for higher clearance, shorter mean residence time and elimination half-life, and lower incremental recovery. Prophylaxis resulted in a median annualized bleeding rate of 0.86 (mean = 2.34) for the combined treatment and continuation phases; 33.3% of participants had zero bleeds; and 83.7% of bleeds treated resolved with 1 or 2 infusions. One adverse event was possibly related to trenonacog alfa, a nonserious hypersensitivity reaction leading to early study termination. The efficacy and safety of trenonacog alfa for prophylaxis and bleeding treatment in previously treated pediatric participants were consistent with those reported for adults and adolescents. There appeared to be no clinically important differences between the results for participants aged <6 years and those aged 6 to <12 years. Conclusion: Trenonacog alfa is a suitable option for the management of pediatric persons with hemophilia B.
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