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Use or Non-Use of Epoetin Beta in Patients Infected by Chronic Hepatitis C
This study is ongoing, but not recruiting participants.
First Received: December 5, 2005   Last Updated: April 17, 2008   History of Changes
Sponsored by: University Hospital, Angers
Information provided by: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT00262379
  Purpose

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


Condition Intervention Phase
Chronic Hepatitis C
Drug: epoetin beta (NeoRecormon®)
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Sustained Viral Response (Week 72)

Secondary Outcome Measures:
  • • 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

Estimated Enrollment: 222
Study Start Date: December 2005
Estimated Study Completion Date: July 2009
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262379

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

No publications provided

Responsible Party: University Hospital Angers ( Pr F. Lunel-Fabiani )
Study ID Numbers: CP 2005-01
Study First Received: December 5, 2005
Last Updated: April 17, 2008
ClinicalTrials.gov Identifier: NCT00262379     History of Changes
Health Authority: France: Ministry of Health

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

Study placed in the following topic categories:
Epoetin Alfa
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Hematinics
Ribavirin
Peginterferon alfa-2a
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:
Epoetin Alfa
Liver Diseases
RNA Virus Infections
Hepatitis, Chronic
Flaviviridae Infections
Hematinics
Hematologic Agents
Hepatitis, Viral, Human
Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Therapeutic Uses
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on August 30, 2009