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Chronic Hepatitis CPhase 3NCT00262379

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

A Phase 3 study testing epoetin beta (NeoRecormon®) in people with Chronic Hepatitis C, run by University Hospital, Angers at 37 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis C
What is being tested?
epoetin beta (NeoRecormon®)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
229 participants
Where
37 sitesFrance
Study dates
Dec 2005to Jun 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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)

Who cannot join

  • 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
Show all 24Show fewer
  • 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
  • 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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

France37 sites

  • H Aix en Provence

    Aix-en-Provence, 13616

  • UH Angers

    Angers, 49933

  • H Avignon

    Avignon, 84 902

  • H Bourgoin-Jallieu

    Bourgoin, 38 317

  • UH Brest

    Brest, 29 609

  • UH Caen

    Caen, 14 033

  • H Châteauroux

    Châteauroux, 36 000

  • UH Clermont Ferrand

    Clermont-Ferrand, 63009

  • H Corbeil-Essonnes

    Corbeil-Essonnes, 91 106

  • H Creil

    Creil, 60 100

  • H Créteil

    Créteil, 94010

  • UH Dijon

    Dijon, 21 079

  • H Dreux

    Dreux, 28100

  • H Freyming-Merlebach

    Freyming-Merlebach, 57 804

  • H Grasse

    Grasse, 06 130

  • UH Grenoble

    Grenoble, 38 043

  • H La Roche sur Yon

    La Roche-sur-Yon, 85925

  • H Le Mans

    Le Mans, 72000

  • UH Limoges

    Limoges, 87042

  • UH Lyon

    Lyon, 69 288

  • H Saint-Joseph

    Marseille, 13 285

  • H Montauban

    Montauban, 82 013

  • H montélimar

    Montélimar, 26 200

  • UH Montpellier

    Montpellier, 34 295

  • UH Nantes

    Nantes, 44 800

  • H Orléans

    Orléans, 45100

  • H Tenon

    Paris, 75 020

  • H saint-Antoine

    Paris, 75 571

  • H Pau

    Pau, 64 011

  • UH Poitiers

    Poitiers, 86 020

  • UH Rennes

    Rennes, 35 043

  • UH Rouen

    Rouen, 76 031

  • H Saint-Dizier

    Saint-Dizier, 52 115

  • Arnault Tzanck Institute

    Saint-Laurent-du-Var, 06721

  • UH Toulouse

    Toulouse, 31 059

  • H Tourcoing

    Tourcoing, 59 208

  • UH Tours

    Tours, 37 170

Other trials in France

About this 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

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

Read the 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
Being tested
epoetin beta (NeoRecormon®)
Keywords
Chronic hepatitis C, peginterferon, ribavirin, epoetin beta
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epoetin beta (NeoRecormon®)Drug

    Also called 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
Study groups in NCT00262379
Study groupRoleWhat they receive
Group ANo interventionHCV treatment with peginterferon plus ribavirin during 48 weeks
GroupbActive comparatorHCV treatment with peginterferon plus ribavirin during 48 weeks plus epoetin beta under anemia conditions
Receives: Drug: epoetin beta (NeoRecormon®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 72

Secondary outcomes (4)

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

    Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 48

    Measured: Week 48

  2. • Quality of life

    • Questionnaire HQLQ
    • Fatigue Severity Scale HQLQ questionnaire and Fatigue Severity Scale

    Measured: D0, W4, W12, W24, W48, W72

  3. • Cumulative dose of ribavirin from D0-W24 and from W24-W48 periods

    • Cumulating dose of ribavirin during following periods D0-W24 and W24-W48

    Measured: D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48

  4. • 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00262379
Sponsor's protocol ID
CP 2005-01
Status last verified
Dec 2014
First submitted
5 Dec 2005
Last updated
12 Dec 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing epoetin beta (NeoRecormon®) in people with Chronic Hepatitis C, run by University Hospital, Angers at 37 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained Viral Response (Week 72) (time frame: Week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00262379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2014.

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