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

Venous Thromboembolism Clinical Trial

Official title:

Safety and Effectiveness of Pradaxa Oral Pellet Formulation for Treatment of Acute Venous Thromboembolic Events (VTE) and/or for Risk Reduction of Recurrence of VTE in Pediatric Patients Aged 3 Months to Less Than 12 Years in a Real World Setting: a Prospective Non-interventional Study Conducted in the United States

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05966740
• Other study ID #: 1160-0309
• Status: Recruiting
• Start date: October 31, 2023
• Est. completion date: June 28, 2029

Study information

• Verified date: April 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: June 28, 2029
• Est. primary completion date: June 28, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Years

Eligibility

Inclusion Criteria:

• 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 venous thromboembolic events (VTE)

• Treatment to reduce the risk of recurrence of VTE

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 Prescribing Information.

• Previous participation in this study.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Dayton Children's Hospital	Dayton	Ohio
United States	Indiana Hemophilia & Thrombrosis Center	Indianapolis	Indiana
United States	University of California, San Diego	La Jolla	California
United States	Rady Children's Hospital	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Children's Hospital Acquired Thrombosis consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of any bleeding-related events		Up to week 52
Secondary	Thrombotic burden at the end of the treatment period vs baseline, i.e. image-based resolution status of the thrombus (complete response, partial response, stable disease, progressive disease)		Baseline and up to week 12
Secondary	Occurrence of any non-contiguous venous thromboembolic events (VTE) while on treatment		Up to week 52
Secondary	Mortality related to thrombotic or thromboembolic events		Up to week 52
Secondary	Occurrence of post-thrombotic syndrome (PTS)		Up to week 52
Secondary	Recurrence of VTE while on treatment		Up to week 52
Secondary	Incidence of adverse events (AEs)		Up to week 52
Secondary	Incidence of serious adverse events (SAEs)		Up to week 52
Secondary	Frequency of patients who discontinued treatment due to an AE		Up to week 52
Secondary	Duration of treatment with dabigatran etexilate		Up to week 52
Secondary	Compliance with dabigatran etexilate treatment		Up to week 52

External Links

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