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An Exploratory Multi-Centre, Multi-National, Randomised, Double Blinded, Parallel Arm Trial Evaluating Safety, Pharmacokinetics and Dose-finding of prophylactic administration of Long Acting rFVIIa (L...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-006424-54

An Exploratory Multi-Centre, Multi-National, Randomised, Double Blinded, Parallel Arm Trial Evaluating Safety, Pharmacokinetics and Dose-finding of prophylactic administration of Long Acting rFVIIa (LA-rFVIIa) in Haemophilia A or B Patients with Inhibitors

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Extrait

The primary objective is to determine the safety including the potential immunogenicity of LArFVIIa intravenously administered to haemophilia patients with inhibitors every second day for 12 weeks at three dose levels 25 µg/kg, 100 µg/kg and 200 µg/kg.

Critère d'inclusion

  • Haemophilia A (Factor VIII) or B with Inhibitors

Liens