Trial reportBlood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis2025
The efficacy, safety, and pharmacokinetics of N8-GP in previously treated Chinese patients with haemophilia A: results from the phase 3b pathfinder10 study.
Trial report in Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05082116 (A Multi-centre, Open-label Trial Evaluating Efficacy, Safety and Pharmacokinetics of Turoctocog Alfa Pegol), which is not on this map. Not yet cited in PubMed.
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A Multi-centre, Open-label Trial Evaluating Efficacy, Safety and Pharmacokinetics of Turoctocog Alfa Pegol (N8-GP) When Used for Treatment and Prophylaxis of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
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Abstract
introductionN8-GP (turoctocog alfa pegol) is a recombinant, glycoPEGylated, extended half-life FVIII replacement product approved for treatment of haemophilia A (HA).
aimThe pathfinder10 (NCT05082116) multicentre, open-label, nonrandomised, single-arm phase 3b trial investigated N8-GP efficacy, safety, and pharmacokinetics in previously treated Chinese patients.
methodsPatients (≥12 years) with severe HA, FVIII activity <1%, ≥150 exposure days to FVIII products, and no FVIII inhibitors (≥0.6 BU) or history were enrolled and received 50 IU/kg N8-GP prophylaxis every four days for ≥28 weeks. Bleeding episodes were treated with 20-75 IU/kg N8-GP. The primary endpoint was the number of treatment-requiring bleeding episodes (spontaneous, traumatic). Secondary endpoints included haemostatic effect, inhibitor rate, FVIII trough activity, and pharmacokinetics.
resultsThirty-six patients completed the trial. During 12 months pretrial, 17 (47%) patients received a mixture of episodic and prophylactic regimens, and 1 (3%) episodic treatment only, and the mean (SD) and median number of bleeding episodes during prophylaxis were 11.0 (11.1) and 5.0. During N8-GP prophylaxis, mean (95% CI) and median ABR were 2.55 (1.24; 5.23) and 0.00. No bleeds were reported in 25/36 patients (69.4%). The haemostatic success rate for bleed treatment was 94.8% (73.2; 99.2). Most bleeds (49/52; 94.2%) were treated with ≤2 injections; 42/52 (80.8%) needed 1 injection. Mean FVIII activity trough level (predose) was 3.3 IU/dl (2.6; 4.3), mean postdose recovery 126.1 IU/dl (116.9; 136.0), N8-GP terminal half-life 19.9 h (18.6, 21.2), 30 min IR 2.28 (IU/dl)/(IU/kg) (2.05, 2.52), and AUC (0-96 h) (single dose) 31.8 h*(IU/ml) (28.9; 34.9). No inhibitors or safety concerns were identified.
conclusionN8-GP appeared safe and efficacious in previously treated Chinese patients with severe HA.
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