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

Sponsor
University Hospital, Angers (Other)
Overall Status
Completed
CT.gov ID
NCT00262379
Collaborator
(none)
229
Enrollment
37
Locations
2
Arms
42
Duration (Months)
6.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Dec 1, 2005
Actual Primary Completion Date :
Jun 1, 2009
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

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 Names:
  • NeoRecormon®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. • 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

    2. • Quality of life [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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-Jallieu France 38 317
    5 UH Brest Brest France 29 609
    6 UH Caen Caen France 14 033
    7 H Châteauroux Châteauroux France 36 000
    8 UH Clermont Ferrand Clermont Ferrand France 63009
    9 H Corbeil-Essonnes Corbeil-Essonnes France 91 106
    10 H Creil Creil France 60 100
    11 H Créteil Créteil France 94010
    12 UH Dijon Dijon France 21 079
    13 H Dreux Dreux France 28100
    14 H Freyming-Merlebach Freyming-Merlebach France 57 804
    15 H Grasse Grasse France 06 130
    16 UH Grenoble Grenoble France 38 043
    17 H La Roche sur Yon La Roche sur Yon France 85925
    18 H Le Mans Le Mans France 72000
    19 UH Limoges Limoges France 87042
    20 UH Lyon Lyon France 69 288
    21 H Saint-Joseph Marseille France 13 285
    22 H Montauban Montauban France 82 013
    23 UH Montpellier Montpellier France 34 295
    24 H montélimar Montélimar France 26 200
    25 UH Nantes Nantes France 44 800
    26 H Orléans Orléans France 45100
    27 H Tenon Paris France 75 020
    28 H saint-Antoine Paris France 75 571
    29 H Pau Pau France 64 011
    30 UH Poitiers Poitiers France 86 020
    31 UH Rennes Rennes France 35 043
    32 UH Rouen Rouen France 76 031
    33 Arnault Tzanck Institute Saint Laurent du Var France 06721
    34 H Saint-Dizier Saint-Dizier France 52 115
    35 UH Toulouse Toulouse France 31 059
    36 H Tourcoing Tourcoing France 59 208
    37 UH Tours Tours France 37 170

    Sponsors and Collaborators

    • University Hospital, Angers

    Investigators

    • Principal Investigator: Françoise Lunel-Fabiani, MD, PhD, UH Angers

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Angers
    ClinicalTrials.gov Identifier:
    NCT00262379
    Other Study ID Numbers:
    • CP 2005-01
    First Posted:
    Dec 6, 2005
    Last Update Posted:
    Dec 12, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by University Hospital, Angers
    Chronic hepatitis C
    peginterferon
    ribavirin
    epoetin beta
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Hepatitis, Chronic
    Epoetin Alfa

    Study Results

    No Results Posted as of Dec 12, 2014