Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients
Status:
Withdrawn
Trial end date:
2019-05-24
Target enrollment:
Participant gender:
Summary
Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with
very high affinity. Idarucizumab potently and specifically binds to dabigatran and its
metabolites and neutralises its anticoagulant effect. A clinical development program is
ongoing to support marketing authorisation submissions for idarucizumab indicated in patients
treated with dabigatran who require emergency surgery/urgent procedures or who have a
life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of
dabigatran is required.