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A Two-Part Study of Safety, Pharmacokinetics, and Efficacy of Telaprevir in Combination With Peginterferon alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus

Mise à jour : Il y a 4 ans
Référence : EUCTR2011-004564-30

Femme et Homme

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Extrait

PART A - To evaluate the short-term safety of telaprevir in combination with peginterferon alfa-2b (Peg-IFN) and ribavirin (RBV) (Peg-IFN/RBV) in treatment-naïve pediatric subjects without cirrhosis - To evaluate the pharmacokinetics (PK) and determine the appropriate dose of telaprevir in combination with Peg-IFN/RBV in treatment-naive pediatric subjects without cirrhosis PART B - To evaluate the safety of telaprevir in combination with Peg-IFN/RBV in treatment-naive and peginterferon/RBV treatment-experienced pediatric subjects with or without cirrhosis

Critère d'inclusion

  • Genotype 1 Hepatitis C Virus

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