Status:
COMPLETED
Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C
Lead Sponsor:
University Hospital, Angers
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 bet...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT00262379
Start Date
December 1 2005
End Date
June 1 2009
Last Update
December 12 2014
Active Locations (37)
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1
H Aix en Provence
Aix-en-Provence, France, 13616
2
UH Angers
Angers, France, 49933
3
H Avignon
Avignon, France, 84 902
4
H Bourgoin-Jallieu
Bourgoin, France, 38 317