Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C
NCT ID: NCT00262379
Last Updated: 2014-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
229 participants
INTERVENTIONAL
2005-12-31
2009-06-30
Brief Summary
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Detailed Description
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* 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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
HCV treatment with peginterferon plus ribavirin during 48 weeks
No interventions assigned to this group
Groupb
HCV treatment with peginterferon plus ribavirin during 48 weeks plus epoetin beta under anemia conditions
epoetin 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
Interventions
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epoetin 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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Principal Investigators
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Françoise Lunel-Fabiani, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UH Angers
Locations
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H Aix en Provence
Aix-en-Provence, , France
UH Angers
Angers, , France
H Avignon
Avignon, , France
H Bourgoin-Jallieu
Bourgoin, , France
UH Brest
Brest, , France
UH Caen
Caen, , France
H Châteauroux
Châteauroux, , France
UH Clermont Ferrand
Clermont-Ferrand, , France
H Corbeil-Essonnes
Corbeil-Essonnes, , France
H Creil
Creil, , France
H Créteil
Créteil, , France
UH Dijon
Dijon, , France
H Dreux
Dreux, , France
H Freyming-Merlebach
Freyming-Merlebach, , France
H Grasse
Grasse, , France
UH Grenoble
Grenoble, , France
H La Roche sur Yon
La Roche-sur-Yon, , France
H Le Mans
Le Mans, , France
UH Limoges
Limoges, , France
UH Lyon
Lyon, , France
H Saint-Joseph
Marseille, , France
H Montauban
Montauban, , France
H montélimar
Montélimar, , France
UH Montpellier
Montpellier, , France
UH Nantes
Nantes, , France
H Orléans
Orléans, , France
H Tenon
Paris, , France
H saint-Antoine
Paris, , France
H Pau
Pau, , France
UH Poitiers
Poitiers, , France
UH Rennes
Rennes, , France
UH Rouen
Rouen, , France
H Saint-Dizier
Saint-Dizier, , France
Arnault Tzanck Institute
Saint-Laurent-du-Var, , France
UH Toulouse
Toulouse, , France
H Tourcoing
Tourcoing, , France
UH Tours
Tours, , France
Countries
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Other Identifiers
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CP 2005-01
Identifier Type: -
Identifier Source: org_study_id