Chronic Hepatitis C
Conditions
Keywords
Chronic hepatitis C, peginterferon, ribavirin, epoetin beta
Brief summary
The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin.
Detailed 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
Interventions
DRUGepoetin beta (NeoRecormon®)
• 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
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Viral Response (Week 72) | Week 72 | Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 24 in the Post-treatment Follow-up Period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • Viral Response at the End of Treatment (Week 48) | Week 48 | Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 48 |
| • Quality of life | D0, W4, W12, W24, W48, W72 | * Questionnaire HQLQ * Fatigue Severity Scale HQLQ questionnaire and Fatigue Severity Scale |
| • Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods | D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48 | • Cumulating dose of ribavirin during following periods D0-W24 and W24-W48 |
| • Clinical and biological tolerance | D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48, W52, W60, W72 | 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 |
Countries
France
Outcome results
None listed