Overview

Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age

Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to older children and adults and to confirm dabigatran etexilate dosing algorithm for children aged less than 1 year.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Dabigatran
Criteria
Inclusion criteria:

- Neonates and infants with aged < 12 months at Visit 1

- Objective diagnosis of VTE

- End of planned treatment course with anticoagulant therapy as per standard of care at
the investigator site.

- Written informed consent provided by the patient's parent(s) (or legal guardian)
according to local regulations at Visit 1.

Exclusion criteria:

- Weight less than 3 kg at Visit 1

- Conditions associated with an increased risk of bleeding

- renal dysfunction

- hepatic disease

- Anemia or thrombocytopenia at screening