Trial reportResearch and practice in thrombosis and haemostasis2026
Immunogenicity, safety, and efficacy of rurioctocog alfa pegol in previously untreated patients with severe hemophilia A.
Trial report in Research and practice in thrombosis and haemostasis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02615691 (Phase 3, Prospective, Multi-center, Open Label Study to Investigate Safety, Immunogenicity and Hemostatic Efficacy of PEGylated Factor VIII), which is not on this map. Not yet cited in PubMed.
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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.
Phase 3, Prospective, Multi-center, Open Label Study to Investigate Safety, Immunogenicity and Hemostatic Efficacy of PEGylated Factor VIII (BAX 855) in Previously Untreated Patients (PUPs) < 6 Years With Severe Hemophilia A (FVIII < 1%)
Who cites it
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Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: In severe hemophilia A, factor VIII (FVIII) replacement is essential, but FVIII inhibitor development can be serious. Objectives: This phase 3, prospective, uncontrolled, open-label, multicenter study (NCT02615691) investigated the immunogenicity, efficacy, and safety of rurioctocog alfa pegol for severe hemophilia A in previously untreated patients. Methods: Patients received intravenous prophylaxis (25-50 IU/kg, up to 80 IU/kg, ≥1 dose weekly) and/or on-demand therapy (10-50 IU/kg, up to 80 IU/kg depending on bleed severity). The primary endpoint was FVIII inhibitor incidence (≥0.6 BU/mL [Nijmegen modification of Bethesda assay]) in the full analysis set (patients with ≥100 exposure-days [EDs] or who developed an inhibitor). We present the final data. Results: Of 146 enrolled patients, 120 received ≥1 dose; all were male, and 55.8% had a family history of hemophilia A. Median (range) age was 9.6 (1.2-60.0) months. In the full analysis set ( Conclusion: These data demonstrate a low incidence of FVIII inhibitors among previously untreated patients receiving rurioctocog alfa pegol for severe hemophilia A. Efficacy and safety results were similar to prior reports in previously treated patients.
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