ArticleHaemophilia : the official journal of the World Federation of Hemophilia2019
A field study evaluating the activity of N8-GP in spiked plasma samples at clinical haemostasis laboratories.
Article in Haemophilia : the official journal of the World Federation of Hemophilia, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 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
8 citing papers in PubMed, 14 citations in OpenAlex.
- Global Comparative Antithrombin Field Study: Impact of Laboratory Assay Variability on the Assessment of Antithrombin Activity Measurement at Fitusiran Clinical Decision-Making Points.Haemophilia : the official journal of the World Federation of Hemophilia · 2025Article
- Plasma Clearance of Coagulation Factor VIII and Extension of Its Half-Life for the Therapy of Hemophilia A: A Critical Review of the Current State of Research and Practice.International journal of molecular sciences · 2023Review
- Measurement of extended half-life recombinant FVIII molecules:Research and practice in thrombosis and haemostasis · 2023Article
- A Review of Factor VIII and Factor IX Assay Methods for Monitoring Extended Half-Life Products in Hemophilia A and B.Methods in molecular biology (Clifton, N.J.) · 2023Review
- An overview of the pathfinder clinical trials program: Long-term efficacy and safety of N8-GP in patients with hemophilia A.Journal of thrombosis and haemostasis : JTH · 2020Review
- An overview of turoctocog alfa pegol (N8-GP; ESPEROCTHaemophilia : the official journal of the World Federation of Hemophilia · 2020Review
- A field study evaluating the activity of N8-GP in spiked plasma samples at clinical haemostasis laboratories.Haemophilia : the official journal of the World Federation of Hemophilia · 2019Article
- Monitoring Extended Half-Life Factor VIII and IX Concentrates: Performance in Routine Clotting-and Thrombin Generation Assays.Haemophilia : the official journal of the World Federation of HemophiliaReview
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
Abstract
aimN8-GP (turoctocog alfa pegol) is a glycoPEGylated, extended half-life human recombinant factor VIII (FVIII) shown to be an efficacious treatment for patients with haemophilia A. Accurate monitoring of replacement therapy helps ensure proper dosing, leading to better patient care. The objective of this field study was to evaluate the accuracy and intra- and inter-laboratory variabilities of N8-GP and rAHF (Advate
methodsLaboratories measured plasma samples spiked with 0.03, 0.2, 0.6 and 0.9 IU/mL N8-GP or rAHF. Samples were blinded, and laboratories were instructed to perform evaluations using their routine FVIII activity assays and calibrators.
resultsOf the 67 participating laboratories from 25 countries, 60 used a one-stage assay, 36 used a chromogenic assay, and 29 used both one-stage and chromogenic assays. Participating laboratories used nine different activated partial thromboplastin time (aPTT) reagents, the most common being SynthASil
conclusionsMost clinical laboratories accurately measured N8-GP and rAHF when using their in-house one-stage or chromogenic FVIII:C assays. However, three silica-based aPTT reagents underestimated N8-GP recovery.
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Registered trials
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