Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C
- Conditions
- Chronic Hepatitis C
- Interventions
- Drug: epoetin beta (NeoRecormon®)
- Registration Number
- NCT00262379
- Lead Sponsor
- University Hospital, Angers
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 229
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Groupb epoetin beta (NeoRecormon®) HCV treatment with peginterferon plus ribavirin during 48 weeks plus epoetin beta under anemia conditions
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method • 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
• 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
• 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
Trial Locations
- Locations (37)
H saint-Antoine
🇫🇷Paris, France
H Saint-Joseph
🇫🇷Marseille, France
UH Grenoble
🇫🇷Grenoble, France
H Montauban
🇫🇷Montauban, France
UH Poitiers
🇫🇷Poitiers, France
H Tourcoing
🇫🇷Tourcoing, France
H Aix en Provence
🇫🇷Aix en Provence, France
H Corbeil-Essonnes
🇫🇷Corbeil-Essonnes, France
H Freyming-Merlebach
🇫🇷Freyming-Merlebach, France
H La Roche sur Yon
🇫🇷La Roche sur Yon, France
UH Limoges
🇫🇷Limoges, France
UH Montpellier
🇫🇷Montpellier, France
H montélimar
🇫🇷Montélimar, France
H Pau
🇫🇷Pau, France
Arnault Tzanck Institute
🇫🇷Saint Laurent du Var, France
H Bourgoin-Jallieu
🇫🇷Bourgoin-Jallieu, France
H Creil
🇫🇷Creil, France
H Dreux
🇫🇷Dreux, France
UH Brest
🇫🇷Brest, France
UH Nantes
🇫🇷Nantes, France
UH Lyon
🇫🇷Lyon, France
UH Dijon
🇫🇷Dijon, France
UH Toulouse
🇫🇷Toulouse, France
UH Angers
🇫🇷Angers, France
UH Clermont Ferrand
🇫🇷Clermont Ferrand, France
H Créteil
🇫🇷Créteil, France
H Grasse
🇫🇷Grasse, France
H Orléans
🇫🇷Orléans, France
UH Rennes
🇫🇷Rennes, France
H Le Mans
🇫🇷Le Mans, France
UH Rouen
🇫🇷Rouen, France
H Tenon
🇫🇷Paris, France
H Saint-Dizier
🇫🇷Saint-Dizier, France
UH Tours
🇫🇷Tours, France
H Avignon
🇫🇷Avignon, France
UH Caen
🇫🇷Caen, France
H Châteauroux
🇫🇷Châteauroux, France