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Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02798107
Collaborator
(none)
0
Enrollment
4
Anticipated Duration (Days)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Purpose:
Study Design:

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Safety of Potential Paediatric Patients Treated With Idarucizumab: a Non-internventional Chart Review Study
Anticipated Study Start Date :
May 20, 2019
Anticipated Primary Completion Date :
May 23, 2019
Anticipated Study Completion Date :
May 24, 2019

Arms and Interventions

Arm Intervention/Treatment
All patients treated with idarucizumab

Drug: idarucizumab
drug

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. Safety outcomes until hospital discharge * Incidence of hypersensitivity/anaphylactic reactions [Up to 33 months]

  3. Safety outcomes until hospital discharge * Incidence of AE, SAE, ADR, SADR reporting [Up to 33 months]

  4. Safety outcomes until hospital discharge * Cause of death and in-hospital mortality rate [Up to 33 months]

Secondary Outcome Measures

  1. 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]

  2. Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of hypersensitivity/anaphylactic reactions [Up to 33 months]

  3. Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of AE, SAE, ADR, SADR reporting [Up to 33 months]

  4. Comparison of patient characteristics of paediatric patients with & without outcome events * Cause of death and in-hospital mortality rate [Up to 33 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02798107
Other Study ID Numbers:
  • 1321.11
First Posted:
Jun 14, 2016
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Hemorrhage

Study Results

No Results Posted as of Nov 18, 2021