Trials / Withdrawn
WithdrawnNCT02798107
Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients
Safety of Potential Paediatric Patients Treated With Idarucizumab: a Non-internventional Chart Review Study
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
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:
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | idarucizumab | drug |
Timeline
- Start date
- 2019-05-20
- Primary completion
- 2019-05-23
- Completion
- 2019-05-24
- First posted
- 2016-06-14
- Last updated
- 2021-11-18
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02798107. Inclusion in this directory is not an endorsement.