A THREE MONTH PROSPECTIVE OPEN LABEL STUDY OF THERAPY WITH FRAGMIN® (DALTEPARIN SODIUM INJECTION) IN CHILDREN WITH VENOUS THROMBOEMBOLISM WITH OR WITHOUT MALIGNANCIES

Mise à jour : Il y a 4 ans
Référence : EUCTR2016-000394-21

Femme et Homme

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Extrait

- To determine the pharmacodynamic (PD) profiles for treatment doses of dalteparin in pediatric subjects of different ages with venous thromboembolism (VTE), and with or without cancer, using anti-Xa (Xa) levels and a population PD analysis methodology. - To determine the median dose (IU/kg) required to achieve therapeutic anti-Xa levels (0.5 to 1.0 International Units [IU]/mL) based on subject age and weight.


Critère d'inclusion

  • Acute treatment and secondary prophylaxis of recurrent VTE (venous thromboembolism) in children with or without cancer