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The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin.
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| • 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 |
| • Quality of life |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Françoise Lunel-Fabiani, MD, PhD | UH Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Aix en Provence | Aix-en-Provence | 13616 | France | |||
| UH Angers |
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|
| D0, W4, W12, W24, W48, W72 |
| • 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 |
| • 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 | D0, W4, W8, W12, W16, W20, W24, W28, W32, W36, W40, W44, W48, W52, W60, W72 |
| Angers |
| 49933 |
| France |
| H Avignon | Avignon | 84 902 | France |
| H Bourgoin-Jallieu | Bourgoin | 38 317 | France |
| UH Brest | Brest | 29 609 | France |
| UH Caen | Caen | 14 033 | France |
| H Châteauroux | Châteauroux | 36 000 | France |
| UH Clermont Ferrand | Clermont-Ferrand | 63009 | France |
| H Corbeil-Essonnes | Corbeil-Essonnes | 91 106 | France |
| H Creil | Creil | 60 100 | France |
| H Créteil | Créteil | 94010 | France |
| UH Dijon | Dijon | 21 079 | France |
| H Dreux | Dreux | 28100 | France |
| H Freyming-Merlebach | Freyming-Merlebach | 57 804 | France |
| H Grasse | Grasse | 06 130 | France |
| UH Grenoble | Grenoble | 38 043 | France |
| H La Roche sur Yon | La Roche-sur-Yon | 85925 | France |
| H Le Mans | Le Mans | 72000 | France |
| UH Limoges | Limoges | 87042 | France |
| UH Lyon | Lyon | 69 288 | France |
| H Saint-Joseph | Marseille | 13 285 | France |
| H Montauban | Montauban | 82 013 | France |
| H montélimar | Montélimar | 26 200 | France |
| UH Montpellier | Montpellier | 34 295 | France |
| UH Nantes | Nantes | 44 800 | France |
| H Orléans | Orléans | 45100 | France |
| H Tenon | Paris | 75 020 | France |
| H saint-Antoine | Paris | 75 571 | France |
| H Pau | Pau | 64 011 | France |
| UH Poitiers | Poitiers | 86 020 | France |
| UH Rennes | Rennes | 35 043 | France |
| UH Rouen | Rouen | 76 031 | France |
| H Saint-Dizier | Saint-Dizier | 52 115 | France |
| Arnault Tzanck Institute | Saint-Laurent-du-Var | 06721 | France |
| UH Toulouse | Toulouse | 31 059 | France |
| H Tourcoing | Tourcoing | 59 208 | France |
| UH Tours | Tours | 37 170 | France |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C103998 | epoetin beta |
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