Trial reportClinical pharmacokinetics2017
Improved Pharmacokinetics with BAY 81-8973 Versus Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method: A Randomized Pharmacokinetic Study in Patients with Severe Hemophilia A.
Trial report in Clinical pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02483208 (Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate), which is not on this map. Cited by 22 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.
Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
Who cites it
22 citing papers in PubMed, 39 citations in OpenAlex.
- BAY 81-8973 Demonstrates Long-Term Safety and Efficacy in Children With Severe Haemophilia A: Results From the LEOPOLD Kids Extension Study.European journal of haematology · 2025Trial
- Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81-8973): Final results of the global real-world study, TAURUS.European journal of haematology · 2023Trial
- Population pharmacokinetic (PopPK) modelling indicates that patients switching to BAY 81-8973 from rFVIII-FS can continue their dosing schedule with improved protection.Haemophilia : the official journal of the World Federation of Hemophilia · 2020Trial
- Increased branching and sialylation of N-linked glycans correlate with an improved pharmacokinetic profile for BAY 81-8973 compared with other full-length rFVIII products.Drug design, development and therapy · 2019Trial
- Damoctocog Alfa Pegol, a PEGylated B-domain Deleted Recombinant Extended Half-life Factor VIII for the Treatment of Hemophilia A: A Product Review.Drugs in R&D · 2024Review
- Bioequivalence of recombinant factor VIII products: a position paper from the Italian Association of Hemophilia Centers.Blood transfusion = Trasfusione del sangue · 2023Article
- Switching from Sucrose-Formulated rFVIII to Octocog Alfa (BAY 81-8973) Prophylaxis Improves Bleed Outcomes in the LEOPOLD Clinical Trials.Journal of blood medicine · 2023Article
- Area under the curve: Comparing the value of factor VIII replacement therapies in haemophilia A.Haemophilia : the official journal of the World Federation of Hemophilia · 2023Article
- Pharmacokinetic parameter driven outcomes model predicts a reduction in bleeding events associated with BAY 81-8973 versus antihemophilic factor (recombinant) plasma/albumin-free method in a Chinese healthcare setting.BMC medical research methodology · 2022Article
- Enhanced pharmacokinetics and reduced bleeds in boys with hemophilia A after switching to Kovaltry from other standard half-life factor VIII concentrates.Research and practice in thrombosis and haemostasis · 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
- External qualification of the Web-Accessible Population Pharmacokinetic Service-Hemophilia (WAPPS-Hemo) models for octocog alfa using real patient data.Research and practice in thrombosis and haemostasis · 2021Article
- Population Pharmacokinetics of Clotting Factor Concentrates and Desmopressin in Hemophilia.Clinical pharmacokinetics · 2021Review
- BAY 81-8973 prophylaxis and pharmacokinetics in haemophilia A: Interim results from the TAURUS study.European journal of haematology · 2020Article
- BAY 81-8973 demonstrated efficacy, safety and joint status improvement in patients with severe haemophilia A in the LEOPOLD I extension for ≤2 years.European journal of haematology · 2020Article
- Favorable Pharmacokinetic Characteristics of Extended-Half-Life Recombinant Factor VIII BAY 94-9027 Enable Robust Individual Profiling Using a Population Pharmacokinetic Approach.Clinical pharmacokinetics · 2020Article
- Relationship between factor VIII activity, bleeds and individual characteristics in severe hemophilia A patients.Haematologica · 2020Article
- Routine clinical care data for population pharmacokinetic modeling: the case for Fanhdi/Alphanate in hemophilia A patients.Journal of pharmacokinetics and pharmacodynamics · 2019Article
- Using pharmacokinetics for tailoring prophylaxis in people with hemophilia switching between clotting factor products: A scoping review.Research and practice in thrombosis and haemostasis · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBAY 81-8973 is a full-length, unmodified, recombinant human factor VIII (FVIII) for the treatment of hemophilia A.
objectiveThe aim of this study was to compare the pharmacokinetic (PK) profile of BAY 81-8973 with antihemophilic factor (recombinant) plasma/albumin-free method (rAHF-PFM) PATIENTS/
methodsIn this phase I, open-label, crossover study, men aged 18-65 years with severe hemophilia A and ≥150 exposure days to FVIII were randomized to receive a single intravenous infusion of 50 IU/kg BAY 81-8973 or rAHF-PFM, followed by crossover to a single infusion of the other treatment. FVIII levels were measured in plasma over 48 h using one-stage and chromogenic assays. PK parameters, including area under the curve from time zero to the last data point (AUC
resultsEighteen patients were randomized and analyzed. Using both assays, geometric mean (coefficient of variation [%CV]) AUC
conclusionsBAY 81-8973 showed a superior PK profile versus rAHF-PFM. The same FVIII trough threshold level could be achieved with lower doses of BAY 81-8973 versus rAHF-PFM. ClinicalTrials.gov: NCT02483208.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.