This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
1200-1600mg/day po
1000-1200mg/day po
360 micrograms sc weekly
180 micrograms sc twice weekly
Unnamed facility
Angers, France
Unnamed facility
Bobigny, France
Unnamed facility
Châteauroux, France
Unnamed facility
Créteil, France
Unnamed facility
Créteil, France
Unnamed facility
Grenoble, France
Unnamed facility
Hyères, France
Unnamed facility
Lille, France
Unnamed facility
Limoges, France
Unnamed facility
Marseille, France
...and 12 more locations
Sustained viral response
Time frame: Week 72
Percentage of patients with >=2log drop of HCV-RNA
Time frame: Week 4, 12, 24.
Percentage of patients with non-detectable HCV-RNA
Time frame: Week 48
Relapse rate
Time frame: Throughout study.
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