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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Angers
• Treatments: Epoetin Alfa; Peginterferon alfa-2a; Ribavirin

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