Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Purpose: Study Design:

Official Title
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Safety of Potential Paediatric Patients Treated With Idarucizumab: a Non-internventional Chart Review Study

Conditions
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Hemorrhage

Intervention / Treatment
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* Drug: idarucizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients treated with idarucizumab<br> | Drug: idarucizumab<br>* drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Up to 33 months | 
| Safety outcomes until hospital discharge * Incidence of hypersensitivity/anaphylactic reactions |  | Up to 33 months | 
| Safety outcomes until hospital discharge * Incidence of AE, SAE, ADR, SADR reporting |  | Up to 33 months | 
| Safety outcomes until hospital discharge * Cause of death and in-hospital mortality rate |  | Up to 33 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Up to 33 months | 
| Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of hypersensitivity/anaphylactic reactions |  | Up to 33 months | 
| Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of AE, SAE, ADR, SADR reporting |  | Up to 33 months | 
| Comparison of patient characteristics of paediatric patients with & without outcome events * Cause of death and in-hospital mortality rate |  | Up to 33 months |