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

Boehringer Ingelheim

Status: Terminated

Conditions: Venous Thromboembolism

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05966740

1160-0309

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 3 months to 12 years old

Volunteers: No Healthy Volunteers

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 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 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.

Trial design

6 participants in 1 patient group

Pediatric patients with VTE and/or at risk for VTE