This multicenter, open-label, uncontrolled study will evaluate the efficacy and safety of increasing the dose of peginterferon alfa-2a (Pegasys) in participants with Genotype 1/4/5/6 CHC and an early non-response to a standard course of peginterferon alfa-2a plus ribavirin. The study will consist of screening (4 weeks), treatment (32 weeks), and follow-up (24 weeks).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Unnamed facility
Antwerp, Belgium
Unnamed facility
Antwerp, Belgium
Unnamed facility
Bruges, Belgium
Percentage of Participants Achieving Virologic Response, as measured by ultrasensitive Roche HCV TaqMan Test
Time frame: Week 12
Percentage of Participants Achieving Sustained Virologic Response (SVR), as measured by ultrasensitive Roche HCV TaqMan Test
Time frame: Week 56
Percentage of Participants Achieving End-of-treatment Response, as measured by ultrasensitive Roche HCV TaqMan Test
Time frame: Week 32
Mean Log Change From Baseline to Week 2, 4, 8, 12, 32, and 56 in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Viral Load
Time frame: Baseline, Week 2, 4, 8, 12, 32, 56
Number of Participants With Adverse Events and Serious Adverse
Time frame: Baseline up to Week 56
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Unnamed facility
Brussels, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Brussels, Belgium
...and 11 more locations