The Janssen Pharmaceutical Companies of Johnson & Johnson has reported positive data from the Phase III UNIVERSE clinical trial, where the oral suspension formulation of Xarelto (rivaroxaban) was linked to reduced blood clots in paediatric Fontan procedure patients.
Patients aged two to eight years with single ventricle physiology and have had the Fontan procedure within four months before enrolment were part of the trial.
Approximately 112 subjects were enrolled across 35 centres in ten countries from November 2016 to June 2019.
The randomised, multicentre, open-label, active-controlled, two-part Phase III trial analysed the use of a new, oral liquid suspension Xarelto formulation versus aspirin in these children.
Part A of the trial assessed the pharmacokinetic (PK) and pharmacodynamic (PD) properties of Xarelto.
Part B analysed the safety and efficacy of the drug against aspirin for thromboprophylaxis for one year.
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Major bleeding events were assessed as the primary safety outcome.
The primary efficacy outcome of the trial was any thrombotic event such as venous or arterial clots, or any thromboembolic event, which includes stroke or a pulmonary embolism.
According to the trial data, a comparable and reduced occurrence of bleeding events was reported with Xarelto versus aspirin.
A major non-fatal bleeding event was reported with Xarelto as against aspirin, with a slightly reduced prevalence of non-major clinically relevant bleeding and trivial bleeding.
The occurrence and pattern of adverse events were similar in both the trial arms.
There were fewer thrombotic events in subjects receiving Xarelto, even though the trial was not powered for efficacy outcomes, the company noted.
Janssen Research and Development Cardiovascular, Metabolism and Retina global therapeutic area head James List said: “The UNIVERSE study is another example of our fulfilment of that promise, and we’re optimistic these findings will generate greater understanding and help to inform guidance for physicians managing thrombotic complications in these vulnerable and high-risk paediatric patients.”
Earlier this month, Janssen reported new data that showed strong prostate-specific antigen response and adherence rates in non-metastatic castration-resistant prostate cancer patients treated with Erleada (apalutamide) in the real-world clinical setting.