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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
epoetin beta (NeoRecormon®)
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic hepatitis C, peginterferon, ribavirin, epoetin beta

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • H Aix en Provence
  • UH Angers
  • H Avignon
  • H Bourgoin-Jallieu
  • UH Brest
  • UH Caen
  • H Châteauroux
  • UH Clermont Ferrand
  • H Corbeil-Essonnes
  • H Creil
  • H Créteil
  • UH Dijon
  • H Dreux
  • H Freyming-Merlebach
  • H Grasse
  • UH Grenoble
  • H La Roche sur Yon
  • H Le Mans
  • UH Limoges
  • UH Lyon
  • H Saint-Joseph
  • H Montauban
  • UH Montpellier
  • H montélimar
  • UH Nantes
  • H Orléans
  • H Tenon
  • H saint-Antoine
  • H Pau
  • UH Poitiers
  • UH Rennes
  • UH Rouen
  • Arnault Tzanck Institute
  • H Saint-Dizier
  • UH Toulouse
  • H Tourcoing
  • UH Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Group A

Groupb

Arm Description

HCV treatment with peginterferon plus ribavirin during 48 weeks

HCV treatment with peginterferon plus ribavirin during 48 weeks plus epoetin beta under anemia conditions

Outcomes

Primary Outcome Measures

Sustained Viral Response (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

• Viral Response at the End of Treatment (Week 48)
Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 48
• Quality of life
Questionnaire HQLQ Fatigue Severity Scale HQLQ questionnaire and Fatigue Severity Scale
• Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods
• Cumulating dose of ribavirin during following periods D0-W24 and W24-W48
• Clinical and biological tolerance
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

Full Information

First Posted
December 5, 2005
Last Updated
December 11, 2014
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT00262379
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Chronic hepatitis C, peginterferon, ribavirin, epoetin beta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
No Intervention
Arm Description
HCV treatment with peginterferon plus ribavirin during 48 weeks
Arm Title
Groupb
Arm Type
Active Comparator
Arm Description
HCV treatment with peginterferon plus ribavirin during 48 weeks plus epoetin beta under anemia conditions
Intervention Type
Drug
Intervention Name(s)
epoetin beta (NeoRecormon®)
Other Intervention Name(s)
NeoRecormon®
Intervention Description
• 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
Primary Outcome Measure Information:
Title
Sustained Viral Response (Week 72)
Description
Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 24 in the Post-treatment Follow-up Period
Time Frame
Week 72
Secondary Outcome Measure Information:
Title
• Viral Response at the End of Treatment (Week 48)
Description
Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 48
Time Frame
Week 48
Title
• Quality of life
Description
Questionnaire HQLQ Fatigue Severity Scale HQLQ questionnaire and Fatigue Severity Scale
Time Frame
D0, W4, W12, W24, W48, W72
Title
• Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods
Description
• Cumulating dose of ribavirin during following periods D0-W24 and W24-W48
Time Frame
D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48
Title
• Clinical and biological tolerance
Description
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
Time Frame
D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48, W52, W60, W72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Françoise Lunel-Fabiani, MD, PhD
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
H Aix en Provence
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
Facility Name
UH Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
H Avignon
City
Avignon
ZIP/Postal Code
84 902
Country
France
Facility Name
H Bourgoin-Jallieu
City
Bourgoin-Jallieu
ZIP/Postal Code
38 317
Country
France
Facility Name
UH Brest
City
Brest
ZIP/Postal Code
29 609
Country
France
Facility Name
UH Caen
City
Caen
ZIP/Postal Code
14 033
Country
France
Facility Name
H Châteauroux
City
Châteauroux
ZIP/Postal Code
36 000
Country
France
Facility Name
UH Clermont Ferrand
City
Clermont Ferrand
ZIP/Postal Code
63009
Country
France
Facility Name
H Corbeil-Essonnes
City
Corbeil-Essonnes
ZIP/Postal Code
91 106
Country
France
Facility Name
H Creil
City
Creil
ZIP/Postal Code
60 100
Country
France
Facility Name
H Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
UH Dijon
City
Dijon
ZIP/Postal Code
21 079
Country
France
Facility Name
H Dreux
City
Dreux
ZIP/Postal Code
28100
Country
France
Facility Name
H Freyming-Merlebach
City
Freyming-Merlebach
ZIP/Postal Code
57 804
Country
France
Facility Name
H Grasse
City
Grasse
ZIP/Postal Code
06 130
Country
France
Facility Name
UH Grenoble
City
Grenoble
ZIP/Postal Code
38 043
Country
France
Facility Name
H La Roche sur Yon
City
La Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
H Le Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
UH Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
UH Lyon
City
Lyon
ZIP/Postal Code
69 288
Country
France
Facility Name
H Saint-Joseph
City
Marseille
ZIP/Postal Code
13 285
Country
France
Facility Name
H Montauban
City
Montauban
ZIP/Postal Code
82 013
Country
France
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34 295
Country
France
Facility Name
H montélimar
City
Montélimar
ZIP/Postal Code
26 200
Country
France
Facility Name
UH Nantes
City
Nantes
ZIP/Postal Code
44 800
Country
France
Facility Name
H Orléans
City
Orléans
ZIP/Postal Code
45100
Country
France
Facility Name
H Tenon
City
Paris
ZIP/Postal Code
75 020
Country
France
Facility Name
H saint-Antoine
City
Paris
ZIP/Postal Code
75 571
Country
France
Facility Name
H Pau
City
Pau
ZIP/Postal Code
64 011
Country
France
Facility Name
UH Poitiers
City
Poitiers
ZIP/Postal Code
86 020
Country
France
Facility Name
UH Rennes
City
Rennes
ZIP/Postal Code
35 043
Country
France
Facility Name
UH Rouen
City
Rouen
ZIP/Postal Code
76 031
Country
France
Facility Name
Arnault Tzanck Institute
City
Saint Laurent du Var
ZIP/Postal Code
06721
Country
France
Facility Name
H Saint-Dizier
City
Saint-Dizier
ZIP/Postal Code
52 115
Country
France
Facility Name
UH Toulouse
City
Toulouse
ZIP/Postal Code
31 059
Country
France
Facility Name
H Tourcoing
City
Tourcoing
ZIP/Postal Code
59 208
Country
France
Facility Name
UH Tours
City
Tours
ZIP/Postal Code
37 170
Country
France

12. IPD Sharing Statement

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

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