Three new trials will evaluate Xarelto for DVT, PE

Janssen Research & Development announced the launch of three new clinical trials to evaluate rivaroxaban for the treatment of deep vein thrombosis and pulmonary embolism.

The new studies are part of the EXPLORER global CV research program for rivaroxaban (Xarelto), which is funded by Janssen and Bayer HealthCare. The program will include more than 11,000 patients in 30 countries, according to a press release.

The phase 3 MARINER study will evaluate the safety and efficacy of once-daily rivaroxaban compared with placebo in reducing the risk for symptomatic deep vein thrombosis (DVT) and/or pulmonary embolism (PE) due to a concurrent medical illness for up to 45 days after hospital discharge. The trial is expected to enroll approximately 8,000 patients in more than 10 countries, according to the release.

The EINSTEIN JUNIOR study program, including phase 1, 2a, 2b and 3 clinical trials, will evaluate rivaroxaban according to an age- and body weight-adjusted dosing schedule for treatment and secondary prevention of DVT and/or PE in pediatric populations. According to the release, the phase 2 trials have begun enrolling and the phase 3 trial is expected to start enrolling in September. The program will include at least 150 patients in 20 countries.

EINSTEIN CHOICE is a phase 3 superiority trial of once-daily rivaroxaban 10 mg and 20 mg compared with aspirin for prevention of symptomatic recurrent DVT and/or PE in patients who have had 6 to 12 months of anticoagulant therapy, according to the release. This trial is expected to enroll approximately 2,850 patients in 31 countries.

Janssen and Bayer HealthCare also announced an agreement with Portola Pharmaceuticals to initiate phase 3 studies of andexanet alfa, an investigational Factor Xa inhibitor reversal agent, for use with rivaroxaban in emergency situations, including patients who have major bleeding or require emergency surgery.

Rivaroxaban is currently approved for six indications.