Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02798107
• Other study ID #: 1321.11
• Status: Withdrawn
• Start date: May 20, 2019
• Est. completion date: May 24, 2019

Study information

• Verified date: November 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Purpose:

Study Design:

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 24, 2019
• Est. primary completion date: May 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Drug:
• idarucizumab
drug

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Safety outcomes until hospital discharge * Incidence of hypersensitivity/anaphylactic reactions		Up to 33 months
Primary	Safety outcomes until hospital discharge * Incidence of AE, SAE, ADR, SADR reporting		Up to 33 months
Primary	Safety outcomes until hospital discharge * Cause of death and in-hospital mortality rate		Up to 33 months
Secondary	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
Secondary	Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of hypersensitivity/anaphylactic reactions		Up to 33 months
Secondary	Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of AE, SAE, ADR, SADR reporting		Up to 33 months
Secondary	Comparison of patient characteristics of paediatric patients with & without outcome events * Cause of death and in-hospital mortality rate		Up to 33 months