Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients

Boehringer Ingelheim

Overview

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.

Purpose: Study Design:

Study Type

OBSERVATIONAL

Conditions

Hemorrhage

Interventions

idarucizumabDRUG

drug

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Safety outcomes until hospital discharge * Incidence of thromboembolic events (ie. obstruction of a blood vessel by the formation of a thrombus - e.g. ischemic stroke, MI, DVT, PE) after administration

Time frame: Up to 33 months

Safety outcomes until hospital discharge * Incidence of hypersensitivity/anaphylactic reactions

Time frame: Up to 33 months

Safety outcomes until hospital discharge * Incidence of AE, SAE, ADR, SADR reporting

Time frame: Up to 33 months

Safety outcomes until hospital discharge * Cause of death and in-hospital mortality rate

Time frame: Up to 33 months

Secondary Outcomes

Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of thromboembolic events (ie. obstruction of a blood vessel by the formation of a thrombus - e.g. ischemic stroke, MI, DVT, PE) after administration

Time frame: Up to 33 months

Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of hypersensitivity/anaphylactic reactions

Time frame: Up to 33 months

Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of AE, SAE, ADR, SADR reporting

Time frame: Up to 33 months

Comparison of patient characteristics of paediatric patients with & without outcome events * Cause of death and in-hospital mortality rate

Time frame: Up to 33 months

Data from ClinicalTrials.gov

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