Trial reportClinical pharmacokinetics2014
Population pharmacokinetic modelling of recombinant factor IX Fc fusion protein (rFIXFc) in patients with haemophilia B.
Trial report in Clinical pharmacokinetics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.
What it found
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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.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 48 citations in OpenAlex.
- Eftrenonacog Alfa: A Review in Haemophilia B.Drugs · 2017Trial
- Extravascular distribution of factor IX-review of experimental and clinical evidence, and relevance for hemophilia B replacement therapy.Research and practice in thrombosis and haemostasis · 2026Review
- Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B.Clinical pharmacokinetics · 2025Article
- Optimization of hemophilia B treatment via population PK modeling of rIX-FP, including a 3-week regimen.Frontiers in pediatrics · 2025Article
- PBPK modeling of recombinant factor IX Fc fusion protein (rFIXFc) and rFIX to characterize the binding to type 4 collagen in the extravascular space.CPT: pharmacometrics & systems pharmacology · 2024Article
- Pharmacokinetic model-based assessment of factor IX prophylaxis treatment regimens in severe hemophilia B.Scientific reports · 2024Article
- Predictive performance of pharmacokinetic-guided prophylactic dosing of factor concentrates in hemophilia A and B.Research and practice in thrombosis and haemostasis · 2024Article
- Eftrenonacog Alfa: A Review in Haemophilia B.Drugs · 2023Review
- [Advances in long-acting recombinant factor Ⅸ for the treatment of hemophilia B].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2022Article
- In silico evaluation of limited sampling strategies for individualized dosing of extended half-life factor IX concentrates in hemophilia B patients.European journal of clinical pharmacology · 2022Article
- Relationship Between Antithymocyte Globulin Concentrations and Lymphocyte Sub-Populations in Kidney Transplant Patients.Clinical pharmacokinetics · 2022Article
- Design of a Prospective Study on Pharmacokinetic-Guided Dosing of Prophylactic Factor Replacement in Hemophilia A and B (OPTI-CLOT TARGET Study).TH open : companion journal to thrombosis and haemostasis · 2022Article
- Population pharmacokinetic modeling of factor concentrates in hemophilia: an overview and evaluation of best practice.Blood advances · 2021Review
- In silico comparison of pharmacokinetic properties of three extended half-life factor IX concentrates.European journal of clinical pharmacology · 2021Article
- Population Pharmacokinetics of Clotting Factor Concentrates and Desmopressin in Hemophilia.Clinical pharmacokinetics · 2021Review
- Real-world assay variability between laboratories in monitoring of recombinant factor IX Fc fusion protein activity in plasma samples.International journal of laboratory hematology · 2020Article
- Excessive breakthrough bleeding in haemophilia B patients on factor IX-albumin fusion protein prophylactic therapy: A single centre case series.Haemophilia : the official journal of the World Federation of Hemophilia · 2020Article
- Routine clinical care data for population pharmacokinetic modeling: the case for Fanhdi/Alphanate in hemophilia A patients.Journal of pharmacokinetics and pharmacodynamics · 2019Article
- Favorable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant factor IX-Fc fusion protein: A randomized trial.Research and practice in thrombosis and haemostasis · 2019Article
- Population Pharmacokinetic Modeling Of On-Demand And Surgical Use Of Nonacog Beta Pegol (N9-GP) And rFIXFc Based Upon The paradigm 7 Comparative Pharmacokinetic Study.Journal of blood medicine · 2019Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesRecombinant factor IX Fc fusion protein (rFIXFc) is a clotting factor developed using monomeric Fc fusion technology to prolong the circulating half-life of factor IX. The objective of this analysis was to elucidate the pharmacokinetic characteristics of rFIXFc in patients with haemophilia B and identify covariates that affect rFIXFc disposition.
methodsPopulation pharmacokinetic analysis using NONMEM(®) was performed with clinical data from two completed trials in previously treated patients with severe to moderate haemophilia B. Twelve patients from a phase 1/2a study and 123 patients from a registrational phase 3 study were included in this population analysis.
resultsA three-compartment model was found to best describe the pharmacokinetics of rFIXFc. For a typical 73 kg patient, the clearance (CL), volume of the central compartment (V 1) and volume of distribution at steady state (V ss) were 2.39 dL/h, 71.4 dL and 198 dL, respectively. Because of repeat pharmacokinetic profiles at week 26 for patients in a subgroup, inclusion of inter-occasion variability (IOV) on CL and V 1 were evaluated and significantly improved the model. The magnitude of IOV on CL and V 1 were both low to moderate (<20 %) and less than the corresponding inter-individual variability. Body weight (BW) was found to be the only significant covariate for rFIXFc disposition. However, the impact of BW was limited, as the BW power exponents on CL and V 1 were 0.436 and 0.396, respectively.
conclusionThis is the first population pharmacokinetic analysis that systematically characterized the pharmacokinetics of long-lasting rFIXFc in patients with haemophilia B. The population pharmacokinetic model for rFIXFc can be utilized to evaluate and optimize dosing regimens for the treatment of patients with haemophilia B.
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