Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients

Boehringer Ingelheim

Status: Withdrawn

Conditions: Hemorrhage

Treatments: Drug: idarucizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02798107

1321.11

Details and patient eligibility

About

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.

Full description

Purpose:

Study Design:

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

All patients treated with idarucizumab

Treatment:

Drug: idarucizumab