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

Open-label, Single Dose, Tolerability, Pharmacokinetic/Pharmacodynamics and Safety Study of Dabigatran Etexilate Given at the End of Standard Anticoagulant Therapy in Children Aged Less Than 1 Year Old

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.

Purpose:

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