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: August 27, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Terminated

Phase

N/A

Condition

Venous Thromboembolism

Venous Thrombosis

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 28, 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

  • University of California, San Diego

    La Jolla 5363943, California 5332921 92093
    United States

    Site Not Available

  • Rady Children's Hospital

    San Diego 5391811, California 5332921 92123
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven 4839366, Connecticut 4831725 06519
    United States

    Site Not Available

  • Johns Hopkins All Children's Hospital

    Saint Petersburg, Florida 33701
    United States

    Site Not Available

  • Johns Hopkins All Children's Hospital

    St. Petersburg 4171563, Florida 4155751 33701
    United States

    Site Not Available

  • Indiana Hemophilia & Thrombrosis Center

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Indiana Hemophilia & Thrombrosis Center

    Indianapolis 4259418, Indiana 4921868 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

  • Cincinnati Children's Hospital

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Site Not Available

  • Dayton Children's Hospital

    Dayton 4509884, Ohio 5165418 45404
    United States

    Site Not Available

  • MUSC (Medical university of South Carolina)

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • MUSC (Medical university of South Carolina)

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Vanderbilt University

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • Dell Children's Ascension

    Austin, Texas 78723
    United States

    Site Not Available

  • Dell Children's Ascension

    Austin 4671654, Texas 4736286 78723
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.