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

Last updated: April 10, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Blood Clots

Venous Thromboembolism

Thromboembolism

Treatment

N/A

Clinical Study ID

NCT05966740
1160-0309
  • Ages 3-12
  • All Genders

Study 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

Inclusion Criteria:

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 ageappropriate

  • Initiation of Pradaxa Pellets administration either as initial or subsequenttherapy:

  • Treatment of VTE

  • Treatment to reduce the risk of recurrence of VTE

Exclusion

Exclusion Criteria:

  • 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 PrescribingInformation.

  • Previous participation in this study.

Study Design

Total Participants: 6
Study Start date:
April 19, 2024
Estimated Completion Date:
April 30, 2025

Connect with a study center

  • University of California, San Diego

    La Jolla, California 92093
    United States

    Site Not Available

  • Rady Children's Hospital

    San Diego, California 92123
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Johns Hopkins All Children's Hospital

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • Indiana Hemophilia & Thrombrosis Center

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Cincinnati Children's Hospital

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Dayton Children's Hospital

    Dayton, Ohio 45404
    United States

    Site Not Available

  • MUSC (Medical university of South Carolina)

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Dell Children's Ascension

    Austin, Texas 78723
    United States

    Site Not Available

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