Hepatitis C, Chronic
Conditions
Brief summary
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.
Interventions
DRUGCopegus
1200-1600mg/day po
DRUGpeginterferon alfa-2a [Pegasys]
360 micrograms sc weekly
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients \>=18 years of age, with CHC genotype 1; * patients who have failed to respond to previous treatment with PEGASYS plus ribavirin for \>=12 weeks; * patients who have discontinued PEGASYS/ribavirin \>=4 weeks prior to enrollment; * compensated liver disease.
Exclusion criteria
* other forms of liver disease; * infection with HIV, HAV, HBV; * hepatocellular cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained viral response | Week 72 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with >=2log drop of HCV-RNA | Week 4, 12, 24. |
| Percentage of patients with non-detectable HCV-RNA | Week 48 |
| Relapse rate | Throughout study. |
Countries
France
Outcome results
None listed