Overview

Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients

Status:
Withdrawn

Trial end date:
2019-05-24

Target enrollment:
0

Participant gender:
All

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.

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Boehringer Ingelheim

Criteria

Inclusion criteria:

- Male or female, <18 years of age

- Were administered idarucizumab at sites and usage identified by various methods
(eg.through the Idarucizumab drug administration surveillance program, spontaneous
reporting)

Exclusion criteria:

Participation in a dabigatran or idarucizumab clinical trial