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Prospective, randomised (using minimisation), double-blind, placebo controlled study to evaluate the safety and efficacy of human normal immunoglobulin as a prophylactic agent against infections in pa...

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-005548-25

Prospective, randomised (using minimisation), double-blind, placebo controlled study to evaluate the safety and efficacy of human normal immunoglobulin as a prophylactic agent against infections in patients with high grade gliomas

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Extrait

To determine the number of infective episodes in patients with high grade gliomas during treatment with 10% intravenous immunoglobulin (Kiovig) compared with placebo (normal saline).

Critère d'inclusion

  • Patients with high-grade gliomas (world health organisation [WHO] grade III or IV) in the first relapse after first-line therapy including chemotherapy with or without nitrososurea, with a life expectancy of at least 6 months and undergoing active treatment with chemotherapy

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