• Profile
Close

Trial establishes dosing and delivery protocols for direct oral anticoagulant in children

American Society of Hematology Annual Meeting Press Release Dec 10, 2019

A phase III clinical trial confirms that children with dangerous blood clots known as VTE can be safely and effectively treated with the direct oral anticoagulant rivaroxaban using formulations and dosing regimens that are tailored for children from birth to age 17.

While direct oral anticoagulants have been approved for treating adults for nearly a decade, the trial is the first to develop a liquid formulation suitable for use in young children.

“This clinical trial program was meant to bring a newer, easier-to-administer, more effective, and safer medication for children – basically, a win-win-win,” said lead study author Guy Young, MD, of the Children’s Hospital Los Angeles Cancer and Blood Disease Institute and the University of Southern California Keck School of Medicine. “We identified the right dose for every single age group and body size from 2 kilograms to almost 140 kilograms, and all the results were within the same range of exposure and efficacy as that seen in adults.”

The trial reported safety and efficacy results in mid-2019, finding that children treated with rivaroxaban had similar rates of recurrent VTE and clinically relevant bleeding as those receiving standard pediatric anticoagulation therapy. The new results shed light on the appropriate dose, schedule, and formulation for administering rivaroxaban to children of various ages and body sizes.

Expanding the use of a drug from adults to children is complicated. One reason is the enormous differential in body size between a newborn baby and an adult-sized teen. In addition, children metabolize drugs differently than adults, which can necessitate giving two to three smaller doses over the course of a day rather than a single larger dose. For drugs like rivaroxaban that were originally developed as a tablet, it is also necessary to create a liquid formulation for young children.

The trial was conducted from 2014-2018 and administered rivaroxaban to 365 children from birth to 17 years old. About 38% of participants received rivaroxaban in tablet form and 62% received the liquid formulation. Participants received the drug once, twice, or three times daily.

The study’s dosing protocols were found to result in a similar level of exposure and similar outcomes in terms of efficacy, bleeding, and adverse events compared to adults receiving a 20 mg tablet of rivaroxaban daily. Imaging results indicated VTE was stabilized or improved in about 80% of children taking rivaroxaban, while just 0.6% experienced symptomatic recurrent VTE. The liquid formulation was also found to be acceptable and palatable.

Children who suffer VTE typically have serious illnesses such as cancer, heart problems, or gastrointestinal disorders, making it challenging to avoid drug interactions when using anticoagulants. Standard options such as coumadin and heparin can be difficult to use alongside other drugs and often require frequent injections and laboratory monitoring. Direct oral anticoagulants are advantageous because they have few drug interactions and are simple to administer, Dr. Young said. 

This article is a news release from American Society of Hematology Annual Press Meeting. Read the original here.

Only Doctors with an M3 India account can read this article. Sign up for free or login with your existing account.
4 reasons why Doctors love M3 India
  • Exclusive Write-ups & Webinars by KOLs

  • Nonloggedininfinity icon
    Daily Quiz by specialty
  • Nonloggedinlock icon
    Paid Market Research Surveys
  • Case discussions, News & Journals' summaries
Sign-up / Log In
x
M3 app logo
Choose easy access to M3 India from your mobile!


M3 instruc arrow
Add M3 India to your Home screen
Tap  Chrome menu  and select "Add to Home screen" to pin the M3 India App to your Home screen
Okay