Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients

NCT02798107 | Withdrawn FDA Drug

• 1 other identifier: 1321.11
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (1)

All patients treated with idarucizumab

Drug: idarucizumab

Interventions

idarucizumab DRUG

drug

All patients treated with idarucizumab

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Any pediatric patient who has received a commercial supply of idarucizumab following market approval in their country

You may qualify if:

• 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)

You may not qualify if:

• Participation in a dabigatran or idarucizumab clinical trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hemorrhage

Interventions

idarucizumab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 14, 2016
• Study Start: May 20, 2019
• Primary Completion: May 23, 2019
• Study Completion: May 24, 2019
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share