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

University Hospital, Angers

Status and phase

Completed

Phase 3

Conditions

Chronic Hepatitis C

Treatments

Drug: epoetin beta (NeoRecormon®)

Study type

Interventional

Funder types

Other

Identifiers

NCT00262379

CP 2005-01

Details and patient eligibility

About

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

Full description

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

Enrollment

229 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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