Status:
TERMINATED
A Study in the United Sates That Looks at the Safety and Effectiveness of Pradaxa Pellets in Children Aged 3 Months to Less Than 12 Years Who Need Treatment of a Blood Clot or Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Children's Hospital Acquired Thrombosis consortium
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
3-12 years
Brief Summary
The main research question of this study is to obtain further safety and effectiveness data on Pradaxa Pellets in children aged 3 months to less than 12 years in routine clinical practice setting.
Eligibility Criteria
Inclusion
- Pediatric patients aged 3 months to less than 12 years at the time of Pradaxa Pellets initiation
- Written informed consent from parents/care givers and patient assent if age appropriate
- Initiation of Pradaxa Pellets administration either as initial or subsequent therapy:
- Treatment of VTE
- Treatment to reduce the risk of recurrence of VTE
Exclusion
- Participation in any randomized clinical trial or use of investigational product, participation in any other observational study is not an exclusion
- Any contraindications to Pradaxa Pellets according to the US Prescribing Information.
- Previous participation in this study.
Key Trial Info
Start Date :
April 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 28 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05966740
Start Date
April 19 2024
End Date
April 28 2025
Last Update
September 4 2025
Active Locations (10)
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1
University of California, San Diego
La Jolla, California, United States, 92093
2
Rady Children's Hospital
San Diego, California, United States, 92123
3
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
4
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701