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Sponsored by: |
University Hospital, Angers |
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Information provided by: | University Hospital, Angers |
ClinicalTrials.gov Identifier: | NCT00262379 |
The purpose is to demonstrate a correction of anemia in hepatitis C virus treatment with peginterferon plus ribavirin.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis C |
Drug: epoetin beta (NeoRecormon®) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 222 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | July 2009 |
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 :
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
UH Angers | |
Angers, France, 49933 | |
UH Limoges | |
Limoges, France, 87042 | |
H Le Mans | |
Le Mans, France, 72000 | |
H Orléans | |
Orléans, France, 45100 | |
H La Roche sur Yon | |
La Roche sur Yon, France, 85925 | |
UH Clermont Ferrand | |
Clermont Ferrand, France, 63009 | |
H Dreux | |
Dreux, France, 28100 | |
H Créteil | |
Créteil, France, 94010 | |
H Aix en Provence | |
Aix en Provence, France, 13616 | |
Arnault Tzanck Institute | |
Saint Laurent du Var, France, 06721 | |
UH Rennes | |
Rennes, France, 35 043 | |
H Corbeil-Essonnes | |
Corbeil-Essonnes, France, 91 106 | |
UH Brest | |
Brest, France, 29 609 | |
H Montauban | |
Montauban, France, 82 013 | |
H Avignon | |
Avignon, France, 84 902 | |
UH Nantes | |
Nantes, France, 44 800 | |
H Freyming-Merlebach | |
Freyming-Merlebach, France, 57 804 | |
UH Grenoble | |
Grenoble, France, 38 043 | |
H Tenon | |
Paris, France, 75 020 | |
UH Poitiers | |
Poitiers, France, 86 020 | |
H montélimar | |
Montélimar, France, 26 200 | |
H Tourcoing | |
Tourcoing, France, 59 208 | |
UH Rouen | |
Rouen, France, 76 031 | |
H Grasse | |
Grasse, France, 06 130 | |
H Pau | |
Pau, France, 64 011 | |
H Saint-Dizier | |
Saint-Dizier, France, 52 115 | |
UH Dijon | |
Dijon, France, 21 079 | |
H saint-Antoine | |
Paris, France, 75 571 | |
H Bourgoin-Jallieu | |
Bourgoin-Jallieu, France, 38 317 | |
H Châteauroux | |
Châteauroux, France, 36 000 | |
UH Lyon | |
Lyon, France, 69 288 | |
H Creil | |
Creil, France, 60 100 | |
UH Montpellier | |
Montpellier, France, 34 295 | |
UH Toulouse | |
Toulouse, France, 31 059 | |
UH Caen | |
Caen, France, 14 033 | |
H Saint-Joseph | |
Marseille, France, 13 285 | |
UH Tours | |
Tours, France, 37 170 |
Principal Investigator: | Françoise Lunel-Fabiani, MD, PhD | UH Angers |
Responsible Party: | University Hospital Angers ( Pr F. Lunel-Fabiani ) |
Study ID Numbers: | CP 2005-01 |
Study First Received: | December 5, 2005 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00262379 |
Health Authority: | France: Ministry of Health |
Chronic hepatitis C peginterferon ribavirin epoetin beta |
Epoetin Alfa Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Ribavirin Peginterferon alfa-2a Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |
RNA Virus Infections Flaviviridae Infections Hematinics |
Therapeutic Uses Hematologic Agents Pharmacologic Actions |