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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Venous Thromboembolism

Treatments: Drug: dabigatran

Study type: Interventional

Funder types: Industry

Identifiers

NCT02223260

1160.105

2014-001259-22 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

Purpose:

Enrollment: 8 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

8 participants in 1 patient group

dabigatran

Experimental group

Description:

open label arm with dabigatran oral liquid formulation as single dose

Treatment:

Drug: dabigatran