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
Stopped early
Conditions studied: Venous Thromboembolism
In brief
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.
Key facts
- Study ID
- NCT05966740
- Run by
- Boehringer Ingelheim
- People needed
- 5
- Starts
- 2024-04-19
- Expected to finish
- 2025-04-28
- Last updated by the study team
- 2026-06-02
Who can join
Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of California, San Diego — La Jolla, California, United States
- Rady Children's Hospital — San Diego, California, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
- Indiana Hemophilia & Thrombrosis Center — Indianapolis, Indiana, United States
- Cincinnati Children's Hospital — Cincinnati, Ohio, United States
- Dayton Children's Hospital — Dayton, Ohio, United States
- MUSC (Medical university of South Carolina) — Charleston, South Carolina, United States
- Vanderbilt University — Nashville, Tennessee, United States
- Dell Children's Ascension — Austin, Texas, United States
Full record on ClinicalTrials.gov
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