Clinical trial NCT00262379: Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C
Official title: Multicenter Study, Randomized and Pragmatic, Comparing Two Therapeutic Strategies : Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C and Treated by Combination Therapy Peginterferon Alfa-2a Plus Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: Chronic hepatitis C
peginterferon
ribavirin
epoetin beta
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2005-12-06
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Sustained Viral Response (Week 72)
timeFrame: Week 72
Secondary outcomes:
measure: • Viral Response at the End of Treatment (Week 48)
timeFrame: Week 48
measure: • Quality of life
timeFrame: D0, W4, W12, W24, W48, W72
measure: • Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods
timeFrame: D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48
measure: • Clinical and biological tolerance
timeFrame: D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48, W52, W60, W72
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: H Aix en Provence
city: Angers
country: France
facility: UH Angers
city: Avignon
country: France
facility: H Avignon
city: Bourgoin-Jallieu
country: France
facility: H Bourgoin-Jallieu
city: Brest
country: France
facility: UH Brest
city: Caen
country: France
facility: UH Caen
city: Châteauroux
country: France
facility: H Châteauroux
city: Clermont Ferrand
country: France
facility: UH Clermont Ferrand
city: Corbeil-Essonnes
country: France
facility: H Corbeil-Essonnes
city: Creil
country: France
facility: H Creil
city: Créteil
country: France
facility: H Créteil
city: Dijon
country: France
facility: UH Dijon
city: Dreux
country: France
facility: H Dreux
city: Freyming-Merlebach
country: France
facility: H Freyming-Merlebach
city: Grasse
country: France
facility: H Grasse
city: Grenoble
country: France
facility: UH Grenoble
city: La Roche sur Yon
country: France
facility: H La Roche sur Yon
city: Le Mans
country: France
facility: H Le Mans
city: Limoges
country: France
facility: UH Limoges
city: Lyon
country: France
facility: UH Lyon
city: Marseille
country: France
facility: H Saint-Joseph
city: Montauban
country: France
facility: H Montauban
city: Montpellier
country: France
facility: UH Montpellier
city: Montélimar
country: France
facility: H montélimar
city: Nantes
country: France
facility: UH Nantes
city: Orléans
country: France
facility: H Orléans
city: Paris
country: France
facility: H Tenon
city: Paris
country: France
facility: H saint-Antoine
city: Pau
country: France
facility: H Pau
city: Poitiers
country: France
facility: UH Poitiers
city: Rennes
country: France
facility: UH Rennes
city: Rouen
country: France
facility: UH Rouen
city: Saint Laurent du Var
country: France
facility: Arnault Tzanck Institute
city: Saint-Dizier
country: France
facility: H Saint-Dizier
city: Toulouse
country: France
facility: UH Toulouse
city: Tourcoing
country: France
facility: H Tourcoing
city: Tours
country: France
facility: UH Tours
Study officials:
affiliation: UH Angers
name: Françoise Lunel-Fabiani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: