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

NCT00262379 | Completed Phase 3 DMC

• 1 other identifier: CP 2005-01
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 37

Brief Summary

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

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C; peginterferon; ribavirin; epoetin beta

Outcome Measures

Primary Outcomes (1)

• 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

  Week 72

Secondary Outcomes (4)

• • Viral Response at the End of Treatment (Week 48)

  Week 48

• • Quality of life

  D0, W4, W12, W24, W48, W72

• • 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

• • Clinical and biological tolerance

  D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48, W52, W60, W72

Study Arms (2)

Group A

NO INTERVENTION

HCV treatment with peginterferon plus ribavirin during 48 weeks

Groupb

ACTIVE COMPARATOR

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

Drug: epoetin beta (NeoRecormon®)

Interventions

epoetin beta (NeoRecormon®) DRUG

• 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

Also known as: NeoRecormon®

Groupb

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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
• 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)

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (37)

H Aix en Provence

Aix-en-Provence, 13616, France

Location

UH Angers

Angers, 49933, France

Location

H Avignon

Avignon, 84 902, France

Location

H Bourgoin-Jallieu

Bourgoin, 38 317, France

Location

UH Brest

Brest, 29 609, France

Location

UH Caen

Caen, 14 033, France

Location

H Châteauroux

Châteauroux, 36 000, France

Location

UH Clermont Ferrand

Clermont-Ferrand, 63009, France

Location

H Corbeil-Essonnes

Corbeil-Essonnes, 91 106, France

Location

H Creil

Creil, 60 100, France

Location

H Créteil

Créteil, 94010, France

Location

UH Dijon

Dijon, 21 079, France

Location

H Dreux

Dreux, 28100, France

Location

H Freyming-Merlebach

Freyming-Merlebach, 57 804, France

Location

H Grasse

Grasse, 06 130, France

Location

UH Grenoble

Grenoble, 38 043, France

Location

H La Roche sur Yon

La Roche-sur-Yon, 85925, France

Location

H Le Mans

Le Mans, 72000, France

Location

UH Limoges

Limoges, 87042, France

Location

UH Lyon

Lyon, 69 288, France

Location

H Saint-Joseph

Marseille, 13 285, France

Location

H Montauban

Montauban, 82 013, France

Location

H montélimar

Montélimar, 26 200, France

Location

UH Montpellier

Montpellier, 34 295, France

Location

UH Nantes

Nantes, 44 800, France

Location

H Orléans

Orléans, 45100, France

Location

H Tenon

Paris, 75 020, France

Location

H saint-Antoine

Paris, 75 571, France

Location

H Pau

Pau, 64 011, France

Location

UH Poitiers

Poitiers, 86 020, France

Location

UH Rennes

Rennes, 35 043, France

Location

UH Rouen

Rouen, 76 031, France

Location

H Saint-Dizier

Saint-Dizier, 52 115, France

Location

Arnault Tzanck Institute

Saint-Laurent-du-Var, 06721, France

Location

UH Toulouse

Toulouse, 31 059, France

Location

H Tourcoing

Tourcoing, 59 208, France

Location

UH Tours

Tours, 37 170, France

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Françoise Lunel-Fabiani, MD, PhD

  UH Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2005
• First Posted: December 6, 2005
• Study Start: December 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

FR (37)