Description:

A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy Inclusion Criteria - adult patients >=18 years of age - CHC infection - liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection - use of 2 forms of contraception during study and 6 months after the study in both men and women - Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks Exclusion Criteria - women who are pregnant or breastfeeding - male partners of women who are pregnant - conditions associated with decompensated liver disease - other forms of liver disease, including liver cancer - human immunodeficiency virus infection

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  1. 12/11/13
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December 11, 2013

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License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00087646 Hepatitis C

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
adult patients >=18 years of age
CHC infection
liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection
use of 2 forms of contraception during study and 6 months after the study in both men and women
Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks
Exclusion criteria
women who are pregnant or breastfeeding
male partners of women who are pregnant
conditions associated with decompensated liver disease
other forms of liver disease, including liver cancer
human immunodeficiency virus infection
Medical Concepts