Trial reportHaemophilia : the official journal of the World Federation of Hemophilia2025
Safety and Use of Eptacog Beta 225 µg/kg in Patients With Haemophilia A or B With Inhibitors.
Trial report in Haemophilia : the official journal of the World Federation of Hemophilia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.
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.
A Phase 1b, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients
A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients With Inhibitors to Factor VIII or IX
A Phase III Study on the Safety, Pharmacokinetics, and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Pediatric Patients From Birth to <12 Years Old With Inhibitors to Factor VIII or IX: PerSept 2
Who cites it
1 citing paper in PubMed.
- Safety and Use of Eptacog Beta 225 µg/kg in Patients With Haemophilia A or B With Inhibitors.Haemophilia : the official journal of the World Federation of Hemophilia · 2025Trial
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
introductionEptacog beta is an activated recombinant human factor VII bypassing agent approved for treating bleeding episodes (BEs) in patients aged ≥12 years with haemophilia A or B with inhibitors. Two initial dose regimens (IDRs) of either 75 or 225 µg/kg, followed by 75 µg/kg, are approved. We examined the safety of eptacog beta 225 µg/kg across completed clinical trials.
methodsThis analysis included data from a Phase 1b trial of single doses of eptacog beta 25, 75 and 225 µg/kg in non-bleeding adults with haemophilia and pooled data from two Phase 3 trials of the 75 and 225 µg/kg IDRs for treating BEs in adolescents and adults (PERSEPT 1) and children (PERSEPT 2).
resultsIn the Phase 1b trial, 10 patients received a single eptacog beta infusion at each dose level. In the Phase 3 trials, 48 patients received the 75 µg/kg IDR (median 20.5 infusions/patient, range 1-137 infusions) and 50 patients received the 225 µg/kg IDR (median 14.5 infusions/patient, range 1-117 infusions). There was a similar incidence of treatment-emergent adverse events (TEAEs) across all doses (225, 75 and 25 µg/kg) in the Phase 1b trial (0.8 vs. 1.0 vs. 2.1 events per infusion, respectively) and with the 225 versus 75 µg/kg IDR in the Phase 3 studies (0.046 vs. 0.029 events per infusion, respectively). No treatment-related serious TEAEs, thromboembolic events, hypersensitivity reactions, deaths attributed to eptacog beta or neutralising antibodies were detected.
conclusionsThese findings demonstrate favourable safety and tolerability regarding the use of the 225 µg/kg IDR.
trial registrationClinicalTrials.gov identifier: NCT01708564, NCT02020369, NCT02448680.
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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.