Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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Purpose:

Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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dabigatran

open label arm with dabigatran oral liquid formulation as single dose

Group Type EXPERIMENTAL

dabigatran

Intervention Type DRUG

Experimental dose chosen based on age and weight

Interventions

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dabigatran

Experimental dose chosen based on age and weight

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No