Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients

Withdrawn

• Conditions: Hemorrhage
• Interventions: Drug: idarucizumab

• Registration Number: NCT02798107
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Purpose:

Study Design:

Study Timeline

• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-14
• Study Start: 2019-05-20
• Primary Completion: 2019-05-23
• Study Completion: 2019-05-24
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients treated with idarucizumab	idarucizumab	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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