Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C
Chronic Hepatitis C
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic hepatitis C, peginterferon, ribavirin, epoetin beta
Eligibility Criteria
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
Sites / Locations
- H Aix en Provence
- UH Angers
- H Avignon
- H Bourgoin-Jallieu
- UH Brest
- UH Caen
- H Châteauroux
- UH Clermont Ferrand
- H Corbeil-Essonnes
- H Creil
- H Créteil
- UH Dijon
- H Dreux
- H Freyming-Merlebach
- H Grasse
- UH Grenoble
- H La Roche sur Yon
- H Le Mans
- UH Limoges
- UH Lyon
- H Saint-Joseph
- H Montauban
- UH Montpellier
- H montélimar
- UH Nantes
- H Orléans
- H Tenon
- H saint-Antoine
- H Pau
- UH Poitiers
- UH Rennes
- UH Rouen
- Arnault Tzanck Institute
- H Saint-Dizier
- UH Toulouse
- H Tourcoing
- UH Tours
Arms of the Study
Arm 1
Arm 2
No Intervention
Active Comparator
Group A
Groupb
HCV treatment with peginterferon plus ribavirin during 48 weeks
HCV treatment with peginterferon plus ribavirin during 48 weeks plus epoetin beta under anemia conditions