Trials / Withdrawn
WithdrawnNCT05536791
A Study in Europe Based on Medical Records That Looks at the Safety of Dabigatran in Children Below 2 Years of Age Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
Safety of Dabigatran Etexilate (DE) for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Paediatric Patients From Birth to Less Than 2 Years of Age: a Prospective European Non-interventional Cohort Study Based on New Data Collection
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
The study is designed to collect and evaluate Dabigatran Etexilate (DE) safety in the context of routine anticoagulation care provided in the European Union (EU)/European Economic Area (EEA) for children under 2 years of age. The non-interventional study will be conducted in paediatric hospitals or paediatric departments of EEA member states where Venous thromboembolism (VTE) patients of the evaluated age group are treated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dabigatran Etexilate (DE) | Dabigatran Etexilate (DE) |
Timeline
- Start date
- 2022-11-24
- Primary completion
- 2024-10-01
- Completion
- 2024-10-01
- First posted
- 2022-09-13
- Last updated
- 2024-06-26
Locations
6 sites across 4 countries: Germany, Netherlands, Spain, Sweden
Source: ClinicalTrials.gov record NCT05536791. Inclusion in this directory is not an endorsement.