The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin.
Show that the correction of anemia by epoetin beta (NeoRecormon®) able to maintain a optimal dose of ribavirin (Copegus®). The study compares two therapeutic strategies : use or non-use of epoetin beta (NeoRecormon®) in patients infected by chronic hepatitis C and treated by combination therapy Peginterferon alfa-2a (Pegasys®) plus ribavirin (Copegus®). The main judgement criteria are : * Sustained Viral Response (Week 72) * Viral Response at the End of Treatment (Week 48) * Quality of life * Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods * Clinical and biological tolerance
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
229
• Prescription of the epoetin beta : when blood concentration of hemoglobin is lower or equal to 12 g/dL in male or lower or equal to 11 g/dL in female
Sustained Viral Response (Week 72)
Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 24 in the Post-treatment Follow-up Period
Time frame: Week 72
• Viral Response at the End of Treatment (Week 48)
Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 48
Time frame: Week 48
• Quality of life
* Questionnaire HQLQ * Fatigue Severity Scale HQLQ questionnaire and Fatigue Severity Scale
Time frame: D0, W4, W12, W24, W48, W72
• Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods
• Cumulating dose of ribavirin during following periods D0-W24 and W24-W48
Time frame: D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48
• Clinical and biological tolerance
Up to 72 weeks, includes all serious and other adverse events that newly occurred or worsened after treatment with PegIFNα-2a, ribavirin or epoetin beta
Time frame: D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48, W52, W60, W72
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