Use or Non-use of Epoetin Beta in Patients Infected by Chronic Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00262379
Recruitment Status : Completed
First Posted : December 6, 2005
Last Update Posted : December 12, 2014
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: epoetin beta (NeoRecormon®) Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Group A
HCV treatment with peginterferon plus ribavirin during 48 weeks
Active Comparator: Groupb
HCV treatment with peginterferon plus ribavirin during 48 weeks plus epoetin beta under anemia conditions
Drug: 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 Name: NeoRecormon®

Primary Outcome Measures :
  1. Sustained Viral Response (Week 72) [ Time Frame: 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 :
  1. • Viral Response at the End of Treatment (Week 48) [ Time Frame: Week 48 ]
    Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 48

  2. • Quality of life [ Time Frame: D0, W4, W12, W24, W48, W72 ]
    • Questionnaire HQLQ
    • Fatigue Severity Scale HQLQ questionnaire and Fatigue Severity Scale

  3. • Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods [ Time Frame: 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

  4. • Clinical and biological tolerance [ Time Frame: 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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00262379

H Aix en Provence
Aix en Provence, France, 13616
UH Angers
Angers, France, 49933
H Avignon
Avignon, France, 84 902
H Bourgoin-Jallieu
Bourgoin-Jallieu, France, 38 317
UH Brest
Brest, France, 29 609
UH Caen
Caen, France, 14 033
H Châteauroux
Châteauroux, France, 36 000
UH Clermont Ferrand
Clermont Ferrand, France, 63009
H Corbeil-Essonnes
Corbeil-Essonnes, France, 91 106
H Creil
Creil, France, 60 100
H Créteil
Créteil, France, 94010
UH Dijon
Dijon, France, 21 079
H Dreux
Dreux, France, 28100
H Freyming-Merlebach
Freyming-Merlebach, France, 57 804
H Grasse
Grasse, France, 06 130
UH Grenoble
Grenoble, France, 38 043
H La Roche sur Yon
La Roche sur Yon, France, 85925
H Le Mans
Le Mans, France, 72000
UH Limoges
Limoges, France, 87042
UH Lyon
Lyon, France, 69 288
H Saint-Joseph
Marseille, France, 13 285
H Montauban
Montauban, France, 82 013
UH Montpellier
Montpellier, France, 34 295
H montélimar
Montélimar, France, 26 200
UH Nantes
Nantes, France, 44 800
H Orléans
Orléans, France, 45100
H Tenon
Paris, France, 75 020
H saint-Antoine
Paris, France, 75 571
H Pau
Pau, France, 64 011
UH Poitiers
Poitiers, France, 86 020
UH Rennes
Rennes, France, 35 043
UH Rouen
Rouen, France, 76 031
Arnault Tzanck Institute
Saint Laurent du Var, France, 06721
H Saint-Dizier
Saint-Dizier, France, 52 115
UH Toulouse
Toulouse, France, 31 059
H Tourcoing
Tourcoing, France, 59 208
UH Tours
Tours, France, 37 170
Sponsors and Collaborators
University Hospital, Angers
Principal Investigator: Françoise Lunel-Fabiani, MD, PhD UH Angers

Responsible Party: University Hospital, Angers Identifier: NCT00262379     History of Changes
Other Study ID Numbers: CP 2005-01
First Posted: December 6, 2005    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Angers:
Chronic hepatitis C
epoetin beta

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Epoetin Alfa
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents