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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262379
• Other study ID #: CP 2005-01
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2005
• Last updated: December 11, 2014
• Start date: December 2005
• Est. completion date: June 2009

Study information

• Verified date: December 2014
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	• Viral Response at the End of Treatment (Week 48)	Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 48	Week 48	No
Secondary	• Quality of life	Questionnaire HQLQ; Fatigue Severity Scale HQLQ questionnaire and Fatigue Severity Scale	D0, W4, W12, W24, W48, W72	No
Secondary	• Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods	• Cumulating dose of ribavirin during following periods D0-W24 and W24-W48	D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48	No
Secondary	• Clinical and biological tolerance	Up to 72 weeks, includes all serious and other adverse events that newly occurred or worsened after treatment with PegIFNa-2a, ribavirin or epoetin beta	D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48, W52, W60, W72	Yes