Clinical trial NCT02798107: Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients
Official title: Safety of Potential Paediatric Patients Treated With Idarucizumab: a Non-internventional Chart Review Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hemorrhage
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-06-14
Enrollment: 0
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any pediatric patient who has received a commercial supply of idarucizumab following market approval in their country

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:

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 33 months
measure: Safety outcomes until hospital discharge * Incidence of hypersensitivity/anaphylactic reactions
timeFrame: Up to 33 months
measure: Safety outcomes until hospital discharge * Incidence of AE, SAE, ADR, SADR reporting
timeFrame: Up to 33 months
measure: Safety outcomes until hospital discharge * Cause of death and in-hospital mortality rate
timeFrame: Up to 33 months
Secondary outcomes:
measure: 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
timeFrame: Up to 33 months
measure: Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of hypersensitivity/anaphylactic reactions
timeFrame: Up to 33 months
measure: Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of AE, SAE, ADR, SADR reporting
timeFrame: Up to 33 months
measure: Comparison of patient characteristics of paediatric patients with & without outcome events * Cause of death and in-hospital mortality rate
timeFrame: Up to 33 months
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: