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
- 12/11/13 12/11/13 - Martin Dugas
December 11, 2013
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Eligibility NCT00087646 Hepatitis C
102518004 (SNOMED CT 2010_0731)
439401001 (SNOMED CT 2010_0731)
128302006 (SNOMED CT 2010_0731)
10008912 (MedDRA 13.1)
103693007 (SNOMED CT 2010_0731)
10061816 (MedDRA 13.1)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
10036586 (MedDRA 13.1)
10006247 (MedDRA 13.1)
10001422 (MedDRA 13.1)
143223008 (SNOMED CT 2010_0731)
10020179 (MedDRA 13.1)