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Randomized, Multicenter, Double-Blinded, Phase IV Study Evaluating the Efficacy (as measured by Sustained Virological Response) and Safety of 360 µg Induction Dosing of Pegasys in Combination with Hig...

Update Il y a 4 ans
Reference: EUCTR2005-005507-41

Randomized, Multicenter, Double-Blinded, Phase IV Study Evaluating the Efficacy (as measured by Sustained Virological Response) and Safety of 360 µg Induction Dosing of Pegasys in Combination with Higher Copegus Doses in Treatment-naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater than or Equal to 85 kg

Woman and Man

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Extract

To compare the efficacy and safety of 360 µg induction dosing of Pegasys for 12 weeks followed by a 180 µg maintenance dose of Pegasys for 36 weeks in combination with Copegus for 48 weeks with the efficacy and safety of 180 µg fixed dosing of Pegasys in combination with Copegus for 48 weeks in patients with genotype 1 chronic hepatitis C infection of high viral titer and baseline body weight equal to or greater than 85 kg

Inclusion criteria

  • genotype 1 chronic hepatitis C infection of high viral titer and baseline body weight greater than or equal to 85 kg

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