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A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple Scleros...

Update Il y a 5 ans
Reference: EUCTR2012-005082-13

A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple Sclerosis Studio di fase I, multicentrico, in aperto, a braccio singolo, a dose multipla per valutare la farmacocinetica e la farmacodinamica di natalizumab in soggetti pediatrici con sclerosi multipla recidivante remittente

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Extract

The primary objective of the study is to determine the PK profile of multiple doses of natalizumab in pediatric subjects with RRMS. L’obiettivo primario dello studio è di determinare il profilo PK di dosi multiple di natalizumab nei soggetti pediatrici affetti da SMRR

Inclusion criteria

  • Relapsing-Remitting Multiple Sclerosis,Sclerosi Multipla recidivante Remittente

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