Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C

Study Overview
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Brief Summary
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The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin.

Detailed Description
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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

Official Title
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Multicenter Study, Randomized and Pragmatic, Comparing Two Therapeutic Strategies : Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C and Treated by Combination Therapy Peginterferon Alfa-2a Plus Ribavirin

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: epoetin beta (NeoRecormon®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients 18 years old or above Patient with French social security or other equivalent health assurance Patient with informed consent Serologic evidence of chronic hepatitis C by detectable anti-HCV antibodies Patient infected by HCV genotype 1, 4, 5 or 6 Compensated liver disease (Child-Pugh ≤ 6) Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior the enrollment in the study All fertile males and females receiving ribavirin must have effective contraception during treatment and during the 6 following months Patient naive of treatment with installation of treatment by investigator following criteria for use Peginterferon alfa-2a (Pegasys) and ribavirin (Copegus) Exclusion Criteria: Women with ongoing pregnancy or breast feeding Male partner of pregnancy woman Minor Major protected by French law for biomedical study Co-infection by HBV or HIV History or other evidence of decompensated liver disease or Child-Pugh score > 6 Clinical or radiological evidence (abdominal ultrasound, CT scan or MRI) of hepatocellular carcinoma IFN or ribavirin at any previous time Patient who received an erythropoetin within 2 months before inclusion History of epilepsy (during the last 6 months) Chronic cardiac insufficiency (stage III or IV in classification from the New York Heart Association [NYHA]) Not controlled portal hypertension Antecedents or risk of venous thrombosis Surgery within 3 months before inclusion Serum creatinine level >15 mg/mL (130µmol/L) Deficiency in vitamin B9 and/or B12 (suspected with macrocytosis > 105 µm3) Thrombocytosis (platelets > 500 000/mm3) Chronic inflammatory syndrome (CRP > 10 mg/L) Deficiency not corrected in iron : Ferritin blood level < 10 µg/L Or - Transferrin saturation coefficient < 20 % History of neoplasia (except basocellular epithelioma and cervical cancer) Contraindications to use epoetin beta or an excipient from molecule to study (urea, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, benzoic acid, benzyl alcohol) Absence of written informed consent Exclusion time for another biomedical study Patient with blood concentration of hemoglobin lower or equal to 12 g/dL for male or lower or equal to 11 g/dL for female

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A<br>HCV treatment with peginterferon plus ribavirin during 48 weeks | |
| Active Comparator: Groupb<br>HCV treatment with peginterferon plus ribavirin during 48 weeks plus epoetin beta under anemia conditions | Drug: epoetin beta (NeoRecormon®)<br>* • 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<br>* Other names: NeoRecormon®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Viral Response at the End of Treatment (Week 48) | Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 48 | Week 48 | 
| • Quality of life | Questionnaire HQLQ Fatigue Severity Scale HQLQ questionnaire and Fatigue Severity Scale | 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 | 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 | D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48, W52, W60, W72 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis C, peginterferon, ribavirin, epoetin beta