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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by University Hospital, Angers.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00262379
First received: December 5, 2005
Last updated: April 17, 2008
Last verified: April 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262379

Locations
France
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
Investigators
Principal Investigator: Françoise Lunel-Fabiani, MD, PhD UH Angers
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Epoetin alfa
Peginterferon alfa-2a
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014